Senior Engineer, Biocompatibility

Job description

Position Summary The Senior Biocompatibility Engineer will play a critical role in ensuring patient safety by overseeing biocompatibility evaluations of medical devices, materials, and processes. This position will collaborate with cross-functional teams to ensure compliance with global regulatory requirements such as ISO 10993. Utilizing expertise in the medical device biocompatibility field to provide guidance throughout the product lifecycle, interpreting regulatory requirements and supporting the biocompatibility strategy team. This position will use analytical skills to review scientific data and assess any gaps, while also making recommendations to mitigate risks. Essential Duties & Responsibilities: Material Compliance & Restricted Substances: - Lead and manage EU MDR-related DHF remediation activities with a focus on legacy material compliance and regulatory gap assessments. - Author verification and validation (V&V) reports specifically addressing restricted substance evaluations in accordance with global regulatory requirements. - Act as the primary contact for supplier declarations of conformity, ensuring documentation aligns with material compliance standards and suppor...