What are the responsibilities and job description for the Biocompatibility Scientist position at The Fountain Groups?
Onsite Branchburg NJ
Pay: $50-$57/hr
REQUIRED:
MS Degree in Biological Sciences or similar
4 years of industry expereince with ISO 10993 Standard (biocompatibility)
- SME for biocompatibility evaluations
- Responsible for:
- Biological evaluation strategies
- Risk assessments
- Supporting regulatory submissions
- Materials / biomaterials
- Device safety patient interaction
Change Control / Lifecycle Support
- Highly sought after
- Supporting on-market product changes:
- Manufacturing changes
- Material changes
Supplier changes
- ISO 10993
- Medical devices / combination products
- Biomaterials / tissue interaction
- Chemistry / biomechanics (nice to have)
Job Description:
- Non-lab biocompatibility SME role (documentation compliance heavy)
- Focus on biological safety / risk assessment for medical devices
- Supports on-market products change control, not just early R&D
- Highly cross-functional: works with R&D, Regulatory, Quality, Engineering
👉 This is NOT a bench scientist role — it’s:
- Scientific strategy
- Regulatory-facing documentation
- Risk assessment ownership
Day-to-Day Responsibilities
- Write and review biocompatibility risk assessments
- Lead or support biocompatibility strategy for projects
- Participate in change control activities
- Collaborate across:
- Regulatory
- Quality
- Engineering
- Monitor and coordinate external studies (CROs)
The Senior Scientist I - Biocompatibility is a SME related to the biocompatibility and nonclinical safety evaluations of medical devices, biomaterials, tissue products, and combination products as a part of Client R&D. This individual must possess an extensive knowledge of ISO-10993 Standards and prior experience working in biocompatibility. The position will be responsible for cross-functional and cross-site collaborations and recommendations of biocompatibility activities, including establishing requirements, planning, execution and approval of biocompatibility requirements in support of regulatory submissions, project teams, operations, with a large focus on manufacturing and change control (product support
Salary : $50 - $57