Senior Engineer, Biocompatibility

Role Overview

• 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.

Requirements

• Must be at least 18 years of age
• Bachelor’s degree in biology, biochemistry, toxicology, pharmaceutical science, pharmacology analytical chemistry or materials science from an accredited college or university is required
• Minimum 7 years of Industry (medical device) experience required
• Proficiency in MS Office and strong written and verbal communication skills
• Ability to work within a fast-paced, changing environment, prioritize tasks, and meet deadlines
• Strong organizational and follow-up skills, attention to detail, and experience working in a cross-division business unit.

Benefits

• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time.
• Expected to be able to complete tasks with minimal supervision.