Job Function Summary:
Lead pre-clinical science and Biocompatibility programs using internal and external resources. Perform scientific risk assessments to support design control activities. Aid in the evaluation of new research and technology initiatives.
Pre-clinical Science and Biocompatibility:
- Lead pre-clinical science and Biocompatibility programs.
- Serve as a subject matter expert in cross-functional team meetings.
- Prepare and defend regulatory documents.
- Provide guidance and risk assessments on new product mat.
- Provide technical leadership for project team activities, team members, peers, and cross functional counterparts.
- Provide oversight for Non-Clinical studies by designing, reviewing, approving and managing studies with Contract Research Organizations (CRO).
- Create Biological Evaluation of Risk (BER) files and maintain compliance of the Design History File.
- Perform scientific risk assessments to support design control activities.
Research and New Technology Evaluations:
- Identify, adapt, and advance new technology initiatives.
- Analyses of test data of new scientific theories and hypotheses.
- Planning, executing, documenting and reporting lab activity to provide scientific date supporting marketing proof points of features on existing and new devices.
- Develop internal procedures and standards for maintenance of laboratory investigation records, quality of invention releases, and feasibility experiment design.
Other Job Functions:
- Assists in special projects as needed.
- Contributes to team effort by accomplishing related duties as requested.
- May include management of technical staff.
Required Knowledge, Skills and Abilities:
- Experience in pre-clinical science/Biocompatibility testing in medical device, pharmaceutical, or biotechnology industries.
- Demonstrated research effectiveness; patents and/or publication in peer review journals, presentations forums, etc.
- Strong statistical analysis skills.
- Excellent communication, interpersonal, writing and computer skills.
- Chemical, medical device, hygiene and/or Packaging industry experience strongly desired.
- Good laboratory and sciences skills expected, including documentation of activity.
- A detailed understanding of the product development process is preferred.
Additional Preferred Knowledge, Skills and Abilities:
- Background in toxicology and experience with toxicological risk analysis.
- Work in a medical device, pharmaceutical, or biotechnology contract research organization (CRO).
- MS/PhD in Physical or Biological science/engineering.
- Minimum of ten-fifteen years of related experience in the medical device industry is required.
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