How to Apply:

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to recruiter@extendmystaff.com. ExtendMyStaff, Inc. partners with Origen to help hire top talent.  If you are selected to move forward in the process, you will be contacted by an ExtendMyStaff representative.  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.

Current Job Openings:

Manufacturing Engineer

Position Summary

The Manufacturing Engineer will evaluate and develop processes to ensure quality, cost and efficiency requirements are met. He/She will troubleshoot problems with production and take corrective actions and will research and make recommendations on the purchase of equipment and/or upgrades to existing equipment.

Essential Duties and Responsibilities

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

  • Design, evaluate, implement and monitor processes and operating systems for the manufacture of medical devices.
  • Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
  • Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
  • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
  • Support the conversion of small-scale processes into commercially viable large-scale operations.
  • Assume responsibility for safety/environmental issues and ongoing performance of processes.
  • Stay up-to-date and follow all Quality System procedures related to this job which can affect the quality of products or services provided to our customers.
  • Select, develop, validate, setup and maintain manufacturing processes, equipment, and tooling.
  • Support production through efficient and effective identification and resolution of line issues.
  • Identify, initiate, and execute process, cost reduction and process improvement projects.
  • Properly document activities in accordance with best engineering practices, company procedures and cGMP, FDA, and ISO 13485 regulatory requirements.  Follow good project management practices.
  • Interface with external vendors to source equipment and fixtures.
  • Effectively train operators, technicians, and engineers on use of equipment and fixtures.
  • Participate and drive continuous improvement projects related to manufacturing.
  • Participate in product development teams to provide input from a manufacturing perspective.
  • Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
  • Knowledgeable in medical device GMP processes in a FDA regulated industry.
  • Provides manufacturing engineering information by answering questions and requests.
  • Design production tooling as required.
  • Experience procedure writing with ability to create, update, implement and improve procedures.
  • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer’s instructions and established procedures; requesting special service.
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
  • Contributes to team effort by accomplishing related results as needed.
  • Central contact for Facility and Equipment Maintenance.
  • Other duties and/or projects as assigned.

Competencies

  • Dealing with Complexity/Ambiguity
  • Informing Others/Communication
  • Curious/Creative
  • Leadership
  • Adaptability
  • Results-driven
  • Technical Capacity
  • Ethical Conduct
  • Communication
  • Decision making
  • Interpersonal skills
  • Self-Awareness/EQ
  • Stress Management

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Engineering and/or equivalent, directly relevant/compatible job experience
  • 4 years’ experience in a small medical device manufacturing environment
  • Experience implementing Demand Flow Technology (DFT) processes
  • Experience in creating Value Stream Mapping (VSM)
  • Experience implementing LEAN manufacturing processes; 6 Sigma Green or Black Belt
  • Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; strong troubleshoot ability
  • Strong ability to understand and interpret customer needs; customer-centric; ability to proactively work with diverse work teams (i.e. Sales, Operations, Human Resources, Quality)
  • 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) with ability to communicate cross-functionally and up/down chain
  • Pays very close attention to detail
  • Self-motivated, hands-on with keen interest in quickly learning and applying new skills/concepts
  • Ability to follow written/verbal instructions and meet deadlines with minimal supervision
  • Ability to react quickly to changing requirements and new processing developments
  • Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel.

Preferred Qualifications

  • Knowledge of Hardware Specifications, Manufacturing Methods and Procedures
  • Progressive experience related to Manufacturing Quality, Product Development, Presenting Technical Information, IQ/OQ/PQ techniques
  • Working/demonstrable knowledge of automation and implementation experience strongly preferred
  • Experience with SolidWorks and Epicor a plus

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 may operate 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.

Salary:

Commensurate with Experience

QA Engineer

Position Summary

The Quality Engineer is responsible for technical duties within the Quality organization including validation and qualification, calibration and customer contact. These duties will support manufacturing operations, customer service, process improvement, and Regulatory requirements.

Essential Duties and Responsibilities

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

  • Administer technical programs within the Quality department, including calibration, sterilizer qualifications and clean room qualifications.
  • Plan and coordinate problem solving, validation and verification.
  • Technical writing to include document development and review.
  • Assists with complaint investigation and follow up required directly with customer.
  • May be required to train and direct others.
  • Assist with technical writing to support regulatory submissions.
  • Develop Root Cause Analysis on problems originating from all sources, from production to end-user.
  • Other duties and/or projects as assigned.

Competencies

  • Self-starter
  • Close attention to detail
  • DOE and validation testing
  • Familiar with quality tools and procedures
  • Broad 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

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Associate’s degree in Science/Math
  • 4+ years’ experience in medical device quality / ISO 13485 environment
  • Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; hands-on troubleshoot ability
  • 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 or participate in a team environment

Preferred Qualifications

  • Engineering or Management degree

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 office environment is usually minimal.

Salary:

Commensurate with Experience.

QA Specialist I/II

Position Summary

The QA (Quality Assurance) Specialist I/II develops programs to support and implement the Quality Management System as developed for OriGen products and processes.  This includes creation of documents and reports on both product quality as well as the effectiveness of the Quality system. Working with the QA Manager (and/or RA/QA Director), they will create a system of continuous improvement for both products and quality reporting.  

Essential Functions

Quality activities include:

  • Write, revise, and approve documents and reports related to quality system activities.
  • Works to increase outgoing product quality
  • Works with suppliers to maintain and improve incoming material quality
  • Works with QA staff to maintain and increase competency and efficiency
  • Manage the Electronic QMS, and train others in its use
  • Assist with document control activities
  • Assist with risk assessment/ risk analysis
  • Performs corrective/preventive action planning and execution
  • Performs complaint investigation and trending
  • Conducts and supervises Internal Audits
  • Prepares for and participates in inspections/audits by external auditing organizations and customers
  • Assists with field actions including FSCAs and recalls
  • Assists in development of Management Review content

Competencies

  • Thorough knowledge of 21 CFR 820, ISO 13485:2016 and MDSAP requirements
  • Familiar with complaint handling, CAPA, Non-conforming material processes, including root cause analysis techniques
  • Familiar with using an eQMS system
  • Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Interpersonal skills necessary to work 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

  • Bachelor’s Degree or equivalent in life science or engineering field
  • Minimum of 3 years’ experience in medical device quality assurance discipline: knowledge of domestic and international medical device quality system regulations and standards

Preferred Education and Experience

  • Certified Internal Auditor (ASQ or similar program)
  • Experience in ERP and eQMS/eDMS systems

Supervisory Responsibility

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

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%

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.

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.

RA Specialist I/II

Position Summary

The RA (Regulatory Affairs) Specialist I/II develops documentation to support the Regulatory objectives for OriGen products.  This staff member works to maintain continuous compliance with domestic and international regulatory requirements and standards.  Working closely with the RA Director, they develop and submit regulatory filings and submissions for authorization to market products in US, EU,  Canada, and other international markets as necessary.

Essential Functions

Regulatory activities include:

  • Executing regulatory strategy by preparing submissions for product approval, responding to requests from reviewers, and resolving deficiencies in submissions.
  • Prepare documentation to support international registration dossiers and maintain product registration files and electronic databases.
  • Monitoring standards for changes in regulatory requirements.
  • Act as regulatory representative on product development teams, providing regulatory input to the engineering/project manager
  • Helps maintain Design History Files (DHF), design dossiers, and technical files following product approval.
  • Working with outside auditors to demonstrate regulatory compliance
  • Support medical device reporting and recall management
  • Working with business partners to investigate regulatory pathways/ develop regulatory strategy for new products and/or changes to existing products.
  • 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.
  • Assists in development of Management Review content

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

  • Bachelor’s Degree or equivalent in life science or engineering field
  • Minimum of 3years’ experience in medical device regulatory affairs discipline: knowledge of domestic and international medical device regulation, practical experience in global registrations and filings (i.e. US, EU, Canada.)

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.

Sr. Financial Analyst

Position Summary

OriGen Biomedical is seeking a Senior Financial Analyst. This person will be responsible for the effective deployment of financial business systems and analytical activity to improve financial and operating performance in the business. This individual contributor position will work closely with the corporate controller and functional business leaders to coordinate all responsibilities by driving streamlined reporting and ad hoc analysis to provide greater insight to our stakeholders. The Senior Financial Analyst will report to the CFO.
Essential Duties and Responsibilities

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

  • Serve as trusted business partner to the corporate function leaders
  • Drive finance process for forecasting, target setting, budgeting in alignment with the corporate timelines
  • Communicate required deliverables clearly and facilitate reviews and trade-off discussions as needed
  • Analyze results to understand performance against plan/forecast thru monitoring of trends and key levers, such as headcount, capital expenditures, operations expenses, and inventory against plan/forecast assumptions
  • Evaluate current pricing structure and current assumptions
  • Communicate results and recommendations to senior business leaders
  • Leverage financial systems to automate and improve current reporting processes
  • Performs effective cost-modeling to direct profitability or assist with risk assessments
  • Develops and implements financial reporting processes and procedures
  • Maintains monthly financial analysis results and forecast publication
  • Adhere to close and reporting deadlines

Competencies

  • Financial Management
  • Leadership
  • Strategic Thought
  • Innovation
  • Adaptability
  • Results-driven
  • Technical Capacity
  • Ethical Conduct
  • Communication
  • Decision making
  • Interpersonal skills

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Minimum of 5+ or more years of progressive experience in the areas of budgeting and financial reporting
  • Thrives in a fast-paced, constantly changing, dynamic environment
  • Superior communication skills
  • Strong organizational skills with the ability to manage multiple tasks and deadlines simultaneously, while demonstrating the ability to delegate tasks appropriately and maintain attention to detail
  • BA/BS degree in Finance or Accounting

Preferred Qualifications

  • 2+ years of using Epicor ERP is ideal
  • 2+ years of more experience in Public accounting preferred
  • Previous experience with Epicor ERP upgrades/implementation desired
  • Strong pricing and cost analyst background is preferred

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.

Salary

Commensurate with Experience.