OriGen Biomedical, Inc. is a growing, privately-held medical device manufacturer founded in 1997 and headquartered in Austin, Texas. We are a leading producer of cryopreservation, cell culture, and respiratory products. Our focus is to produce a range of products to support the treatment of respiratory distress, cancer, genetic conditions, and other life-threatening diseases. Our products are proudly designed with the patient and user in mind and we strive to maintain excellent customer service to ensure that patient care is always the top priority. The primary way to achieve this goal is to hire the right people that share our vision.

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Unique Products Made

Current Job Openings

How to Apply: Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to hr@origenbio.com. Unfortunately, due to the volume of candidates, it is not possible to follow up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

Associate Director of Marketing

Position Summary

The Associate Director of Marketing is responsible for ensuring customer satisfaction with the medical device products the company delivers, maintaining and increasing sales, and assisting in complying with global regulatory requirements. This position will manage the marketing team.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Advocate for and work within a medium size medical device firm
  • Provide clear and concise reporting on marketing functions
  • Develop and implement Marketing plans to ethically promote sales
  • Actualize the marketing plans through established and new commercial channels
  • Identify new target markets
  • Identify new product ideas as found through market research
  • Promote OriGen’s products and brand globally
  • Communicate with the world through social media responsibly
  • Develop new promotional materials, in print, online, for trade shows, and through new channels, as identified
  • Works with all departments to ensure Marketing practices meet regulatory limitations
  • Participates in all phases of Product Design
  • Participates in Strategic Planning
  • Leads their team to achieve deadlines on time and on budget
  • Work towards OKRs for the marketing department

Competencies

  • Proven Leadership Skills
  • Working knowledge of Regulatory environment for medical devices, CFR, 13485. MDR
  • Cost-conscious, small company attitude
  • Excellent communication and interpersonal skills
  • Superior organizational and time management skills
  • Sales planning and forecasting skills
  • Business skills in contract law
  • Sound decision making
  • Ethical Conduct
  • Close attention to detail
  • Broad creativity and curiosity
  • Effective problem-solving skills
  • Adaptability, can work with changing priorities

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Marketing
  • 4+ years experience in medical device marketing
  • 1+ years recent experience in CFR / ISO 13485 environment
  • Ability to understand and interpret customer inputs; ability to work across all departments (i.e. Regulatory, Operations, Human Resources, Engineering)
  • Ability to work independently and lead in a team environment

Preferred Qualifications

  • Masters’ degree in Business
  • 1+ years of leadership experience

Supervisory Responsibility

This position has direct supervision of a department of 1-5 people. The individual will also be required to lead specialized project teams and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

This job may work in a cleanroom environment. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail. Click here for our contact information.

Cleanroom Supervisor for Medical Device Production - Morning Shift

Position Summary

The Clean Room Supervisor ensures that all areas of product assembly, testing and packaging are all following Origen’s cGMP and EN/ISO 9001 policies and procedures. This is to be accomplished through proper assembler training, certification, team building and paying attention to details. This position entails working on established products; although there will be occasions that new product development will be built for engineering qualification and validation. Plan and deliver production requirements for OriGen products

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Manage production by supervising building sub-assemblies or complete assemblies.
  • Direct supervision of Line Leads and operators to ensure timely closure of build lots with proper documentation and reconciliation of manufacturing lots produced.
  • Take ownership of manufacturing in the clean room from; Line clearance to final assembly including testing and packaging, processing documentation, sterilization, inventory to the warehouse. Build requirements will include Production, Engineering, R&D and Rework.
  • Maintain OriGen’s training procedures and certification for operators as well as encouraging a safe and pleasant working environment.
  • Create weekly schedule for the clean room builds and prioritize builds as required.
  • Processing and documenting product assembly and packaging in accordance with cGMP and EN/ISO 9001 requirements according to OriGen’s internal policies and procedures.
  • Provide daily report on clean room builds with detail failure modes and support root cause analysis.
  • Support design and process verification/validation testing and reporting, and suggest design or process improvement ideas for cost reduction or quality improvement.
  • Support development of MP’s for new products and review them for accuracy.
  • Perform and document testing following protocols; provide evaluation report to engineering.
  • Ensure that all responsibilities within the scope of this job comply with the OriGen Quality System.
  • Handle manufacturing related documentation including ECOs, BOMs, Rework Instructions, NCR’s, and CAPA’s.
  • Ensure clean room supplies inventory is maintained at adequate level, and all equipment in use is calibrated and operational.
  • Timely documentation of manufacturing lots and support of closing work orders.
  • Coordinating proper resource allocation according to weekly production schedule.
  • Ensure MP and Router conformance for GMP and EN/ISO standards in work area.
  • Ensure daily instructions and process changes are understood and followed.
  • Make sure operators have sufficient work materials to complete tasks and/or notify proper people.
  • Ensure material and documentation availability with operators for production builds.

Required Skill Sets

  • Requires a 2 year Technical Degree and 3+ years’ Manufacturing/Assembly supervisory experience.
  • Must have the ability to organize, prioritize and work with a wide variety of people.
  • Supervisory experience in medical devices is highly preferred as is a 4-year Technical Degree

Competencies

  • Strong communication skills both verbal and written
  • Basic arithmetic
  • Well developed problem solving skills to make sound technical decisions
  • Microsoft Office, Agile, SAP
  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Basic computer navigation and program knowledge
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment

Preferred Qualifications

  • Prior Clean Room experience preferred
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required

Supervisory Responsibility

Daily staffing and production lot number assignments, delegating tasks to line leads and operators. Supervise and train line leads and operators for build requirements. Evaluate and complete appraisals for line leads and operators in accordance with OriGen’s standard process.

Work Environment

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clean and non-frayed pants/scrubs completely covering the legs and/or a full pants/body “bunny suit”. Personnel may also be required to wear company-provided cleanroom coat, bouffant, face mask, and gloves.

  • Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required.
  • Due to extremely detailed nature of work, may be required to submit to periodic post-employment vision screening and be willing/able to wear corrective eye wear if deemed necessary/appropriate.
  • Note: OriGen is a fragrance, smoke, smokeless tobacco and vape-free facility. There is NO use of any tobacco or vape products permitted anywhere on company grounds/property or during any shift, break or lunch period.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Compensation

Based on experience and ability

Cleanroom Tool Tech

Position Summary

The Clean Room Tool Technician is responsible for troubleshooting problems related to equipment and tooling and providing support to production. He/she will perform maintenance of equipment and the facilities. He/she will aid in the setup and qualification of equipment.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Perform preventative maintenance and calibration for tooling and equipment
  • Ensure PM and Calibration target dates are achieved to support production needs
  • Analyze and correct tooling and equipment issues. Deactivate/ reactivate as necessary
  • Ensure that all responsibilities within the scope of this job comply with the scope of the OriGen Quality System
  • Handle manufacturing related documentation including ECO’s, bill of materials, routers, rework instructions, NCR’s, CAPA’s
  • Ensure test/ engineering lab supplies inventory is maintained at an adequate level
  • Troubleshoot issues with equipment, both electrical and mechanical
  • Maintain facilities infrastructure and equipment for OriGen
  • Assist engineers in developing, building, or testing prototypes, processes, or procedures
  • Execute protocol for equipment qualification
  • Train operators and technicians on use of equipment and fixtures
  • Understand and follow all rules related to GMP, documentation and clean room requirements
  • Any other duties required within the job role

Competencies

  • Mechanical skills
  • Technical Capacity
  • Communication
  • Interpersonal skills

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • High school diploma or equivalent
  • Minimum 2 years’ experience in manufacturing environment
  • Experience in troubleshooting and repairing a range of electro-mechanical production equipment
  • Familiarity with cleanroom environments preferred
  • Strong interpersonal and people skills
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Strong and effective communication skills (verbal and written) will be expected to communicate directly with production management, production technicians, engineers, and senior management
  • Pays close attention to detail
  • Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Compensation

Based on experience and ability

Continuous Improvement Project Manager

Position Summary

The Continuous Improvement Project Manager is responsible for technical duties within the organization including improvement projects, Kaizen, and lean cultural integration. These duties will support manufacturing operations efficiency gains, improved quality outcomes, customer satisfaction, process improvement, and general regulatory compliance.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Lead OriGen continuous improvement (CI) program in a cross functional environment.
  • Plan and coordinate continuous improvement initiatives across all functional groups of the company.
  • Work with senior management to establish budgetary goals for improvement activities.
  • Suggest resources for CI initiatives.
  • Lead and assists with improvement projects and follow up with stakeholders.
  • Provide Technical support for procedural improvements.
  • Develop and sustain organizational continuous improvement plan to solve current operational and organizational challenges.
  • Identify resource gaps to senior management for CI plan.
  • Performs process analysis for cost reduction, quality improvement, and improved efficiency.
  • Assist in development of critical success measures for planned initiatives.
  • Monitor and follow up on implemented initiatives to ensure continued success.
  • Present CI updates and milestones achieved during semiannual management review.
  • Participate in Site Validation Master Plan team.
  • May be required to train and direct others in Continuous Improvement tools.
  • Other duties and/or projects as assigned.

Competencies

  • Self-starter
  • Good math, technical writing and computer skills
  • Close attention to detail
  • DOE and validation experience
  • Familiar with quality improvement tools (e.g., TQM, Lean Manufacturing, etc.)
  • Broad creativity and natural curiosity
  • Organizational and time management skills
  • Problem-solving skills
  • Ethical Conduct
  • Communication and interpersonal skills
  • Adaptability
  • Results-driven
  • Decision making
  • Strong presentation and leading meeting skills
  • Kaizen, VSM, 5S, DMAIC, other continuous improvement tools.

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor degree (STEM)
  • 4+ years’ experience in medical device quality / Continuous Improvement / ISO 13485 environment.
  • 3+ years’ technical expert in Lean Manufacturing tools and principles including set-up reduction, standardized work, and value stream mapping, has general knowledge of other related disciplines.
  • Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; hands-on troubleshoot ability.
  • Ability to understand and interpret customer and business needs.
  • Ability to work with all work functions. (i.e., Regulatory, Operations, Human Resources, Engineering, etc.)
  • Ability to work independently and lead or participate in team environment.

Preferred Qualifications

  • Engineering or Management degree
  • Lean Manufacturing or Lean-Six Sigma certified
  • Green Belt Certification (Internal or ASQ)

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

This job periodically operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Position Type and Expected Hours of Work

This is a full-time position.

Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. In some cases, additional work hours may be required.

Travel

0%

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail. Click here for our contact information.

Customer Service Representative I

The Customer Service Representative I shall be responsible for primary customer contact.  They will be the first point of contact for customer service calls, emails, and fax;  they must remain friendly and courteous at all times. Candidate is expected to develop an understanding of the product lines and be able to quickly assist customers with requests, inquiries and orders.  A comprehensive understanding of OriGen Products will be required/expected.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • The Customer Service Representative I will create new customer accounts
  • Assist with phone answering
  • Candidate must have a friendly and courteous telephone persona, be able to take phone orders
  • Accurately transfer all orders sent via fax, email or take over the phone to our ERP system
  • Confirm to the customer via email the details of the order including estimated ship date
  • Coordinate with Production for any products requiring a lead time and communicate that to the customer
  • Responsible for assisting customers with returns, and following up with Accounting to ensure that credit notes are sent or refunds issued
  • Issue both verbal and written quotes as needed
  • Careful organization of work and timely responses are required
  • Ship customer samples both domestically and internationally
  • Cross training with logistics on customer shipment and perform duties as needed/ assigned
  • Other duties as assigned

Skill set

  • Proven skills in coordinating and managing day to day tasks, problem solving, and working in a collaborative, team environment to meet deadlines and accomplish goals/objectives.
  • Knowledge and skill in using computer software and hardware applications, including Microsoft Word and Excel.
  • Outstanding communication skills, both written and oral –  must communicate effectively with directly with production management, production technicians, engineers, and senior management.

Competencies

  • Results-driven
  • Technical Capacity
  • Ethical Conduct
  • Communication
  • Decision making
  • Interpersonal skills
  • Stress Management

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • High School Degree
  • One year of customer service experience
  • Strong ability to understand and interpret customer needs
  • Strong interpersonal and people skills
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Strong and effective communication skills (verbal and written)
  • Pays very close attention to detail
  • Ability to work independently and within a team environment on assigned projects from inception to completion

Preferred Qualifications

  • Two years of related experience
  • Experience in Medical Devices or Regulatory environment

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.

Purchasing Specialist

Position Summary

The Purchasing Specialist will perform and manage plant supply chain activities. This involves ensuring the continuous supply of high quality, low cost raw materials to keep daily operations running, while maintaining and reporting metrics that allow us to evaluate the performance of our suppliers. In conjunction confirming materials and capacity, planning and scheduling production work orders is required to meet master schedule requirements. Further tasks include but are not limited to managing inventory levels of raw material and managing inbound and outbound logistics.

Essential Duties and Responsibilities

  • Review and analyze weekly requirements generated by Epicor to determine what materials should be purchased.
  • Generate and track purchase orders for raw materials in order to ensure on time delivery.
  • Review and determine the availability of materials and capacity to meet the schedule in order to ensure that the production of final products meets customer needs.
  • Verify the availability of materials, weekly, relative to the production plan and make necessary adjustments to the weekly build schedule.
  • Manage inbound and outbound logistics to optimize the lead time, transportation costs, customs and regulatory clearances.
  • Evaluate Supplier Quality (in conjunction with Quality Assurance Engineer) and Delivery Performance and provide feedback to the supply base.
  • Work with the supply base to ensure timely delivery of supplier documentation (invoices, CoCs, etc.) to ensure a smooth flow of goods through the logistics pipeline as well as Incoming Quality Assurance.
  • Manage the return of rejected products with the supply base and follow up to receive the credit for the returned product.
  • Review and approve change orders in order to determine the impact of changes on material in the warehouse, on order and work in process. Work to minimize obsolescence.
  • Maintain MRP data in Epicor to ensure that the Epicor requirements correctly generate new raw material purchases.
  • Drive improvements in quality, cost and delivery of supplied components.
  • Coordinate the inspection of first articles when needed.
  • Resolve inventory discrepancies as appropriate.
  • Comply with all requirements, duties and obligations of our Quality Management System.
  • Comply with healthy and safety initiatives, policies and procedures. Identify opportunities to improve health and safety.
  • Safeguard all documents, confidential information, equipment, tools, raw materials, products or other assets directly related to their area of ​​work.

Required Skill Sets

  • Must be proficient on computer, possessing intermediate/ advanced navigation and program knowledge
  • Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • 3 years of supply chain experience
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment

Preferred Qualifications

  • B.S. or Masters degree in Engineering or Business Administration. 5 years of supply chain experience. At least 3 years experience in purchasing and production planning.
  • APICS CPIM certification. Experience in logistics and warehouse operations. Medical device experience preferred.
  • Knowledge and use of Epicor.

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clean and non-frayed pants/scrubs completely covering the legs and/or a full pants/body “bunny suit”. Personnel may also be required to wear company-provided cleanroom coat, bouffant, face mask, and gloves.

  • Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required.
  • Due to extremely detailed nature of work, may be required to submit to periodic post-employment vision screening and be willing/able to wear corrective eye wear if deemed necessary/appropriate.
  • Note: OriGen is a fragrance, smoke, smokeless tobacco and vape-free facility. There is NO use of any tobacco or vape products permitted anywhere on company grounds/property or during any shift, break or lunch period.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers. The employee is frequently required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.

Salary:

Commensurate with Experience.

Regulatory Affairs Specialist

Position Summary

OriGen Biomedical is a global leader in cryopreservation and cell culture. We collaborate with top researchers, clinicians and business partners to enhance solutions, improve patient outcomes, and achieve customer satisfaction by providing safe and effective products that positively impact the quality of life.

Reporting directly to the Director of Quality and Regulatory Affairs, the Regulatory Affairs Specialist will interface daily with Manufacturing, Operations, Research and Development, Customer Service, and Marketing in our corporate offices in Austin, TX.

Essential Functions

Regulatory activities include:

  • Develops regulatory submission applications for introduction of new or modified devices, new or expanded indications for use, or changes to the manufacturing/quality processes.
  • Participates in project teams for purposes of identifying regulatory requirements for market approvals.
  • Writes summary technical reports for regulatory submissions and responds to registration requests from regulatory authorities.
  • Plans for and orchestrates meetings with regulatory officials for purposes related to market approval.
  • Maintains regulatory files to ensure the Company’s compliance with regulatory requirements.
  • Develops, reviews, and approves quality system documentation such as Regulatory strategic plans, procedures, verification, and validation protocols and reports, and investigations (e.g., complaint or CAPA).
  • Collaborates with Engineering, Quality, Operations, and Marketing to fulfill design control activities and other Product Development Projects / New Product deliverables.
  • Develops and maintains strong, positive business relationships with key internal customers such as Engineering, Quality, Sales and Marketing, and Operations to fulfill design development activities, establish regulatory project timelines.
  • Ensures that procedures and processes are maintained and updated to be consistent with regulatory requirements; Leads effective meetings, conducts presentations, keeps and maintains regulatory and quality records, and meeting minutes.
  • Working closely with Quality during audits/inspections.
  • Develops and maintains effective relationships with internal and external stakeholders to facilitate regulatory submission planning and execution.
  • Interacts with external industry or regulatory bodies.
  • Work closely with Marketing to develop and implement strategies that will ensure company compliance with regulatory requirements and timely marketing approval or product registration.
  • Manage and coordinate multiple large projects while guiding internal customers on regulatory requirements.
  • Collaborate with regulatory representative(s) of international Distributors and/or Affiliates to ensure continued compliance with international regulations.

Competencies

  • Proven skills in preparing regulatory submissions in the US and Europe (510(k), de Novo and Technical Files). Experience with international regulatory submissions is a plus.
  • Knowledge of FDA regulations and guidelines, including 21 CFR 820.
  • Knowledge of MDR requirements.
  • Knowledge of ISO 13485: 2016 and MDSAP.
  • Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Interpersonal skills necessary for working effectively in a team environment.
  • Works cross functionally to complete projects and testing.
  • Exercises judgment within broadly defined practices and policies.
  • Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.
  • Outstanding communication skills, both written and oral, in communicating across the organization and outside of the organization

Required Education and Experience

  • A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
  • 5+ years of relevant experience interfacing with the FDA and international regulatory agencies.
  • Knowledge of pertinent regulations in major jurisdictions (Europe, U.S., Canada).
  • Experience in the medical device industry preparing regulatory submissions (510(k), CE Marking, EU MDR Tech Files for Class II products, Health Canada, etc.).
  • Experience in development and implementation of regulatory processes and procedures.

Preferred Education and Experience

  • Completion of RAPS Regulatory Affairs Certification program.
  • RAC certification by examination desired.

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

This job periodically operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Position Type and Expected Hours of Work

This is a full-time position.

Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. In some cases, additional work hours may be required.

Travel

5%

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

Salary:

Commensurate with Experience.

Regulatory / Clinical Specialist

Position Summary

The Regulatory/ Clinical Specialist is a key cross-over role between regulatory affairs, regulatory compliance, and clinical affairs. This professional develops and delivers strategy and documentation to support regulatory and clinical objectives within the organization in order to obtain and maintain regulatory approvals and compliance with domestic and international medical device requirements. This staff member is the primary person responsible for delivering clinical strategy, organizing necessary clinical studies or registries, and writing clinical documentation to support access into global markets and support claims desired by OriGen.

Essential Functions

CLINICAL:

  • Developing clinical strategy for on-market or new products, based on new or changing global requirements (such as European Medical Device Regulations 2017/45)
  • Preparing documentation to support clinical deliverables of Technical Documentation, including but not limited to the Clinical Evaluation Report and Post-Market Clinical Follow-Up plans and reports.
  • Managing the planning, organization, execution and results analysis and reporting for any necessary clinical trials or registries, potentially including identifying and collaborating with outsourced CROs.
  • Managing and executing usability studies per ISO 62366
  • Participating in pre-submission meetings with FDA, if needed, to discuss clinical data requirements for new products in the US and presenting justifications for criteria, endpoints, size, and type of clinical trial (i.e. for an IDE or other pre-approval study)
  • Performing literature searches, appraisals, and data analysis for CER and PMS/PSUR
  • Working with marketing and account managers to collect and maintain OriGen literature library
  • Along with account managers, acting as clinical subject matter expert in regards to user risks/ UFMEA and providing input as to clinical hazards and harms
  • Reviewing marketing claims to ensure that they are in alignment with clinical and/or usability validations and data
  • Ensuring any executed clinical studies are in compliance with applicable laws, regulations and guidelines, including GCPs and ISO 14155

REGULATORY:

  • Preparing regulatory submissions for product approval, responding to requests from reviewers, and resolving deficiencies in submissions
  • Creating and maintaining Technical Documentation (as per EU Regulation 2017/745)
  • Preparing documentation to support international registration dossiers and maintain product registration files and electronic registration listing databases
  • Assisting in monitoring and evaluating standards and regulations for changes in regulatory requirements that are applicable to OriGen and OriGen’s products
  • Acting as regulatory representative or independent reviewer on product development teams, providing input to the engineering/project manager
  • Acting as a regulatory/clinical subject matter expert (SME) in on-site audits/inspections
  • Supporting and executing medical device and vigilance reporting, field actions, and recall management
  • Perform regulatory assessment on product or process changes and execute necessary actions such as new 510ks, letters to file, technical file updates, license amendments, etc.
  • Reviewing marketing literature and labeling to ensure claims are in line with indications and validations, as well as verifying that global content requirements are met
  • Executing post-market surveillance (PMS) activities, including PMS Plans, PMS Reports, and PSUR (periodic safety update reports)

Competencies

  • Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives
  • Interpersonal skills necessary for working effectively in a team environment
  • Works cross functionally to complete projects and testing
  • Exercises judgment and makes sound decisions within broadly defined practices and policies
  • High emotional intelligence and ability to navigate conflict and complex issues
  • Problem-solver at all organizational levels – focused on what is best for OriGen
  • Outstanding communication skills, both written and oral, in communicating across and outside of the organization
  • Ability to actively listen, evaluate alternatives and articulate options, thoughts and ideas
  • High personal and professional integrity and emotional maturity
  • Able to accept positive and constructive feedback with grace, interest and poise
  • Strong ability to influence and persuade

Skillsets & Qualifications

  • Superb technical and clinical writing skills
  • Strong background in statistics and data analysis
  • Experience preparing regulatory submissions/ documentation for at least the US and EU
  • General knowledge of 21 CFR 820 and ISO 13485:2016 requirements
  • Thorough knowledge of GCPs and ISO 14155
  • Thorough knowledge of FDA regulations and guidelines
  • Thorough knowledge of MDR (EU Regulation 2017/745) requirements, particularly in regards to clinical requirements
  • Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.

Required Education and Experience

  • Bachelor’s Degree or equivalent in life science or engineering field
  • Minimum of 4 years’ experience in medical device regulatory and/or clinical affairs, including as a CRA (may be composed of any combination of regulatory and clinical roles and responsibilities)
  • Demonstrated knowledge and application of domestic and international medical device regulatory and clinical regulations, standards, and best practices

Preferred Education and Experience

  • Certified CRA/CRC or other clinical research certification desired
  • RAC certification is a plus

Supervisory Responsibility

No direct supervisory responsibility is expected for this role, although project management responsibilities may necessitate leadership skills

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This job periodically operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Position Type and Expected Hours of Work

This is a full-time position.  Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. In some cases, additional work hours may be required.

Travel

5-10%

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

Salary:

Commensurate with Experience.

Warehouse Lead - Second Shift

Position Summary

The Warehouse Lead is responsible for leading and directing the warehouse team in operations within our fulfillment center in Austin, TX. Required to understand and comply with drawings, written procedures, batch records and apply these standards to their work. This professional multitasker will manage and oversee the receiving, handling, storing, picking, and packing activities within the warehouse, ensuring quality standards are met. You must achieve inventory accuracy, coordinate orders, and track shipping times, ultimately overseeing the cross-functional fulfillment of product orders.

As a team lead, you will be the contact point for all team members. You will possess the ability to be a team player and are expected to escalate issues to management for resolutions. You should lead by setting a good example and engage the team to achieve daily goals. Oversee production in accordance to OriGen’s policies and procedures.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Supervise daily activities of the warehouse, including quality assurance, inventory control, space management, logistics, floor productivity, shipping, and customer service
  • Schedule and oversee warehouse team to meet the demands of the fulfillment center, and manage the flow and quality of work to maximize efficiency and minimize overtime
  • Inspect equipment, tools, and machinery regularly, and oversee general maintenance as needed. Ability to work with a variety of tools and equipment
  • Meet regularly with warehouse staff to review, analyze, and develop actionable plans for increased productivity, efficiency and communication and loss prevention
  • Produce reports and statistics regularly, provide metrics and ad hoc reports as needed
  • Oversee and manage logistics utilized to transport products to customers and internal facilities, communicating with drivers and air partners to ensure efficient delivery of packages
  • Report problems or concerns with quality, processes, equipment, materials and staffing to Operations Manager or designee.
    • Ability to meet production schedules and deadlines according to quality standards
  • Ability to work in a flexible and changing environment
  • Able to communicate, delegate and motivate in a positive manner
  • Motivate team members to meet production goals
  • Ability to follow detailed written and verbal instructions
  • Trains members on warehouse processes
  • Ability to learn multiple tasks and train in other areas as needed
  • Ability to maintain all logs, paperwork and forms accurately
  • Required to understand, access and make entries to documents on the company Electronic Document System
  • Ability to accurately perform job duties with minimum supervision
  • Ability to adhere to cleanroom dress code and policies
  • Ability to work in a multi-cultural team environment and be a team player
  • Ability to work in a cleanroom environment for extended periods of time
  • Be punctual and reliable
  • Other duties and/or projects as assigned

Required Skill Sets

  • Must be detailed oriented
  • Must be proficient on computer, possessing basic navigation and program knowledge
  • Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Basic computer navigation and program knowledge
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment
  • High school diploma or GED
  • Forklift Certification and Valid Driver License
  • Proficient knowledge of warehouse procedure and policy
  • Excellent problem-solving skills and leadership qualities
  • Ability to work with all levels of company staff
  • Comfortable delivering frequent direct written and oral feedback

Preferred Qualifications

  • Prior warehouse experience preferred
  • 1+ years’ experience in a leadership role in warehouse environment
  • Knowledge of warehousing Key Performance Indicators (KPIs)
  • Knowledge of Lean concepts

Supervisory Responsibility

This position has no supervisory responsibilities. This position may be required to lead/report on projects and ensure participants meet deadlines.

Work Environment

This job operates in a climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur.

This job may also operate in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand, walk, climb, sit, stoop, bend and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operated automated warehouse equipment; e.g. electric pallet jack, forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail. Click here for our contact information.

Cleanroom Tech for Medical Device Production - Morning and Evening Shift

Morning Shift: Work hours: five days, 8 hour shifts (Monday-Friday 5:45am – 2:15pm).

Evening Shift: Work hours: four days, 10 hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for: assembly, testing, and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Ability to meet production schedules and deadlines according to quality standards
  • Ability to work in a flexible and changing environment
  • Ability to follow detailed written and verbal instructions
  • Ability to learn multiple tasks and train in other areas as needed
  • Ability to work with a variety of tools and equipment
  • Ability to maintain all logs, paperwork, and forms accurately
  • Required to understand, access, and make entries to documents on the company Electronic Document System
  • Ability to accurately perform job duties with minimum supervision
  • Ability to adhere to cleanroom dress code and policies
  • Ability to work in a multi-cultural team environment and be a team player
  • Ability to work in a cleanroom environment for extended periods of time
  • Punctual and Reliable!!

Required Skill Sets

  • Must be detailed oriented and be able to focus on a repetitive task for long periods of time
  • Must be proficient on a computer, possessing basic navigation and program knowledge
  • Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Basic computer navigation and program knowledge
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment  

Preferred Qualifications

  • Prior Clean Room experience preferred

Compensation

Based on experience and ability

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Why Work at OriGen Biomedical

Are you looking for a job that excites and inspires you while making a difference in people’s lives?

Working at OriGen means you are directly making an impact on patient lives. Our products are used in the treatment of various conditions and life-threatening diseases. You’ll enjoy a positive, stimulating, and inclusive environment – with opportunities to grow, all while making a difference.

Our Full-Time Benefits

The physical, mental, and financial health of our employees and their families is a top priority for OriGen. This is why we have a strong, competitive benefits program, which includes:

  • Competitive pay with possibilities of bonuses and merit-based raises
  • Health, vision, and dental insurance plans available
  • Base level health insurance is free to the employee with a $500 contribution to your Health Savings Account by OriGen
  • Employer-paid long-term disability and life insurance up to 1 year of employee’s annual salary
  • 401(k) Retirement Savings Plan with up to 4% matching contribution
  • Flexible work schedule for most office staff
  • Generous paid time off, including ten company holidays, paternity/maternity leave, and bereavement leave
  • Employee Stock Ownership Program (ESOP)
  • Home office improvement incentives for remote workers
  • Awards and recognition
  • Professional development and training opportunities
  • Two different schedules for production employees
    • 1st shift: M-F 5:45am – 2:15pm
    • 2nd shift: M-Th 2:15pm – 12:45am (includes differential pay)

Our Vision

To be the supplier of choice for single-use disposables within cell and gene therapy.

Our Credo

While our primary responsibility is to the patients who ultimately receive our product, our second responsibility is to our staff, the men and women who work for OriGen. We believe each employee should have a sense of security in their job, fair and adequate wages, as well as clean and orderly working conditions. Management must be qualified and just, and the working environment pleasant.

Core Values

  • Be an example of Corporate Responsibility
  • Demonstrate excellence in all aspects of the company
  • Foster incremental innovation
  • Provide unparalleled customer service
  • Advancement opportunity based on merit
  • Our work should benefit the community and the world

What Makes Working at OriGen Unique

We not only improve the lives of our customers and their patients, but we also try to improve the lives of our own employees by fostering good company culture. OriGen offers a friendly workplace, where individuals treat each other with respect and kindness. Meaningful interactions between colleagues are encouraged. We are always looking to nurture talent and provide opportunities to progress, which is why we often fill available roles from within.

OriGen frequently offers fun in-office activities, lead by the Culture Club, whose sole mission is to provide fun ways for employees to engage with one another.

We are a woman-led business and strive to provide an inclusive workplace for all employees no matter their age, race, gender, ethnicity, religion, sexual orientation, differing abilities, or veteran status.

Safety and Pandemic Protocols

OriGen Biomedical manufactures essential, life-saving products.  As such, OriGen is an essential business and some jobs may be required to work onsite. Your health and safety is important, and while we take pride in our everyday practices to maintain a clean and sanitary environment within our facilities, at present, we have implemented additional measures that reflect the recommended standards of the Centers for Disease Control and Prevention (CDC) in response to the coronavirus.

If needed or desired, masks are available to all employees. Continuous sanitization and cleaning measures are done throughout the day. Workstations and desks are arranged in a manner to maintain a distance of 6 feet.

OriGen has maintained operations throughout the entirety of the pandemic to date, adjusting and adapting as necessary.

Our Mission: We create medical products which improve people’s lives.