Job Function Summary
Manage Biocompatibility program by documenting and coordinating testing to support sustaining engineering and new product development activities. Perform scientific risk assessments to support design control activities.
Pre-clinical Science and Biocompatibility:
- Manage Biocompatibility studies by writing protocols, coordinating testing between internal and external testing resources, and insuring that studies are completed on time and within budget.
- Serve as department representative in cross-functional team meetings.
- Provide technical input into 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.
- Develop internal procedures and standards for maintenance of Biocompatibility program as required.
- Assists in special projects as needed.
- Contributes to team effort by accomplishing related duties as requested.
Required Knowledge, Skills and Abilities:
- Experience in pre-clinical science/Biocompatibility testing in medical device, pharmaceutical, or biotechnology industries.
- Demonstrated ability to manage project deliverables and manage timelines.
- Strong statistical analysis skills.
- Excellent communication, interpersonal, writing and computer skills.
- Experience with GLP (21 CFR 58) regulations 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) and serving as a study director.
- BS/MS in Physical or Biological science/engineering.
- Minimum of 5-10 years of related experience in the medical device industry is required.
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