Senior Engineer, Biocompatibility

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.

• 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 supports international regulatory filings.
• Develop and maintain a comprehensive database of raw materials, capturing compliance attributes across multiple global markets.
• Support the Regulatory and Biological Safety teams by performing chemical characterization analysis per ISO 10993, 18562, and EU MDR requirements.
• Draft/author reprocessing testing procedures for reusable medical devices.
• Conduct performance gap assessments related to restricted substances in V&V protocols, production results, lab data, and biocompatibility studies.
• Review and contribute to Biological Evaluation Reports (BERs), ensuring alignment with ISO 10993 and restricted substance regulations.