OriGen Biomedical™ 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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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.

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.

Director, QA/Regulatory

Director of Quality Assurance and Regulatory Affairs in Austin, TX

Located in Austin Texas, we are a well-established, fast-growing, medium size medical device company specializing in devices for cryopreservation and cell culture. We are currently looking for an experienced Quality Assurance and Regulatory Affairs (QA/RA) Director to join our team.

Position Summary

The Regulatory Affairs Director is responsible ensuring compliance with global medical device regulations including CFR, ISO 13485 and MDSAP requirements. This position will manage both the Regulatory and Quality staff.

Essential Duties and Responsibilities

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

  • Develops a forward-looking compliance program to maintain global distribution of medical devices.
  • Advocate for and work within a medium size device firm.
  • Ensures that the Quality System requirements are established and maintained as described in applicable FDA and International Standards.
  • Provide clear and concise reporting on QA and RA functions.
  • Technical writing, direction and submission of Regulatory documentation.
  • Manage and improve the Quality function through direct report supervisors.
  • Oversees Quality Assurance functions, including
    • All internal and external audits
    • CAPA, complaints and MRBs
    • Supplier assessment
    • Training programs
    • Design control
  • Maintains and updates Technical Files on company’s devices.
  • Works with other departments to integrate Regulatory and Quality requirements into all processes.
  • Assists our Distributors in meeting local regulatory requirements.
  • Leads their team to achieve deadlines on time and on budget.
  • Participates in all phases of Product Design.
  • Participates in Strategic Planning.

Competencies

  • Proven Leadership Skills
  • Intimate 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
  • 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 Science/Math/Engineering
  • 10+ years’ experience in QA / RA in medical device manufacturing
  • 5+ years of leadership experience
  • 4+ years’ recent experience in CFR / ISO 13485 environment
  • Audit experience with FDA and Notified Bodies
  • Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
  • Ability to work independently and lead in a team environment

Preferred Qualifications

  • Masters’ degree in a related discipline
  • Professional certification preferred (ASQ CQA, CQE, C Q. Mgr, CQA-Biomedical, RAC)

Supervisory Responsibility

This position supervises of a department of ten and growing.  The individual may also be required to lead 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 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 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.

IT Engineer

Position Summary

The IT Engineer is responsible for maintaining and upgrading computer hardware and software systems.

Essential Duties and Responsibilities

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

  • Provides User support on hardware and software
  • Does Network repairs, upgrades and troubleshooting
  • Technical writing
  • Work in a highly regulated industry
  • Administration and support of Salesforce platform and Epicor ERP system
  • Administration and maintenance of Windows Active Directory and SQL Server
  • Creation and support of reports in SQL Server Reporting Services
  • Provides support for site security policies and processes, including but not limited to developing policies for successful implementation across the business (both physical and cyber-security)

Competencies

  • Experience with SQL databases
  • Good interpersonal skills

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Computer Science/Math/Engineering
  • Ability to understand and interpret customer needs; ability to work with all departments (i.e. Regulatory, Operations, Human Resources, Engineering)
  • Ability to work independently and lead in a team environment

Preferred Qualifications

  • Experience with Epicor ERP software suite
  • Experience with Salesforce/BarTender/SQL Server

Supervisory Responsibility

This position has no direct supervision. The individual may also be required to lead 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 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 60 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 but there may be increased noise or fumes in the warehouse and/or shipping and receiving areas.

Salary:

Commensurate with Experience

QA Technician, Inspector

The QA Technician, Inspector works with limited supervision to conduct incoming, in-process, and final product inspection; support the control and disposition of nonconforming materials and supplier corrective actions; calibrate equipment; create, finalize and maintain quality records; process customer returns; and print product labels.

Essential Duties and Responsibilities

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

  • Performs inspections of incoming, in-process, and final product for conformance to quality assurance standards using an approved sampling plan.
  • Accurately completes all quality control documentation and inspection sheets in accordance with ISO 13485 Standard and established procedures.
  • Verify inspection equipment, machinery and tools used are calibrated per company policy.
  • Follows verbal and/or written instructions such as production traveler, work instruction, process specifications, and drawings at the direction of supervisor in completing a variety of inspection tasks.
  • Makes decisions as to the acceptable quality; determines reasons for rejection; completes required quality records.
  • Identify, initiate quarantine, report and document all nonconforming product.
  • Bring problems/issues to attention of Management.
  • Work efficiently to achieve targeted goals as set by the production schedule.
  • Participates and/or assists with cross training activities, training of new hires and temporary staff.
  • Follows set training program for position and ensures training requirements are up to date.
  • Demonstrates safe work habits, maintains a clean and safe work area.
  • Performs other duties as assigned, to maintain efficiency throughout the company.
  • Conducts equipment calibration activities, requiring a good understanding of current metrology practices and the use of measuring instruments.

Competencies

  • Self-starter
  • Close attention to detail
  • Ability to perform product inspections, including understanding of drawing dimensions and tolerances.
  • Understanding of the selection and use of sampling plans.
  • Familiar with quality tools and procedures
  • Creativity and curiosity
  • Organizational and time management skills
  • Good math, technical writing, and computer skills.
  • Effective problem-solving skills
  • Ethical Conduct
  • Communication and interpersonal skills
  • Adaptability, can work with changing priorities
  • Measured decision making
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • High school diploma
  • 1 – 3+ years’ experience working within a formalized FDA or ISO Quality System.
  • 1 – 3+ years’ experience within a medical device manufacturing environment.

Preferred Qualifications

  • Associate degree or professional certification

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.

  • Due to the extremely detailed nature of work, may be required to submit to periodic post-employment vision screening and be willing/able to wear corrective eyewear 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 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.

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 innovative medical products which improve people’s lives.