Scientist II - Biocompatibility
AbbVie
June 27, 2026
On-site
Branchburg, NJ
$78,500 - $141,000 USD yearly
Clinical Research and Development
Main Responsibilities:
- Function as a representative for ISO-10993 (biocompatibility) assessments: design, execute, interpret biocompatibility evaluation strategies/programs, including biological risk assessments and technical documentation for internal/external distribution and regulatory submissions.
- Support biocompatibility project plans with realistic deliverables and timelines; plan, execute, and manage experimental studies for safety/efficacy characterization of new and existing products.
- Serve as a dedicated biocompatibility resource for product development teams; provide technical knowledge for cross-functional project initiatives.
- Maintain knowledge of medical device regulations; ensure compliance for evaluation programs, including gap analyses for changes to standards/guidance and updates to internal product files.
- Prepare/deliver technical presentations and assist with functional training.
- Support global change control activities related to biocompatibility.
- Build/maintain relationships with Contract Research Organizations, toxicologists, and consultants for biological risk assessments.
Qualifications:
- Bachelor’s in Life Science/Biomedical Engineering or related field with 7+ years scientific experience in medical device/pharma; or Master’s with 5+ years.
- Medical device/pharmaceutical or regulated-environment experience supporting patient safety studies (preferred).
- Experience/working knowledge of medical device and combination product regulations.
- Strong working knowledge of ISO-10993 standards, FDA guidance/regulations, and animal welfare regulations.
- Strong technical writing and verbal communication skills; self-motivated and able to work with minimal supervision.
- Ability to communicate complex technical information clearly; familiarity with product development process for medical devices/biologics.
- Critical thinking/problem-solving with data analysis/presentation.
- Knowledge of Good Documentation Practices and Good Laboratory Practices (21 CFR Part 58).
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees).
Onsite:
- Branchburg, NJ office.
- Function as a representative for ISO-10993 (biocompatibility) assessments: design, execute, interpret biocompatibility evaluation strategies/programs, including biological risk assessments and technical documentation for internal/external distribution and regulatory submissions.
- Support biocompatibility project plans with realistic deliverables and timelines; plan, execute, and manage experimental studies for safety/efficacy characterization of new and existing products.
- Serve as a dedicated biocompatibility resource for product development teams; provide technical knowledge for cross-functional project initiatives.
- Maintain knowledge of medical device regulations; ensure compliance for evaluation programs, including gap analyses for changes to standards/guidance and updates to internal product files.
- Prepare/deliver technical presentations and assist with functional training.
- Support global change control activities related to biocompatibility.
- Build/maintain relationships with Contract Research Organizations, toxicologists, and consultants for biological risk assessments.
Qualifications:
- Bachelor’s in Life Science/Biomedical Engineering or related field with 7+ years scientific experience in medical device/pharma; or Master’s with 5+ years.
- Medical device/pharmaceutical or regulated-environment experience supporting patient safety studies (preferred).
- Experience/working knowledge of medical device and combination product regulations.
- Strong working knowledge of ISO-10993 standards, FDA guidance/regulations, and animal welfare regulations.
- Strong technical writing and verbal communication skills; self-motivated and able to work with minimal supervision.
- Ability to communicate complex technical information clearly; familiarity with product development process for medical devices/biologics.
- Critical thinking/problem-solving with data analysis/presentation.
- Knowledge of Good Documentation Practices and Good Laboratory Practices (21 CFR Part 58).
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees).
Onsite:
- Branchburg, NJ office.