Biocompatibility and Sterility Assurance Manager

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Biocompatibility and Sterility Assurance Manager in United States.

This role provides hands-on technical leadership for biocompatibility, sterilization, and contamination control programs for advanced medical devices. The Biocompatibility and Sterility Assurance Manager will serve as the primary subject-matter expert, collaborating closely with R&D, Quality, Regulatory, Operations, and external labs to ensure compliance with ISO standards and FDA regulations. This position is ideal for a detail-oriented professional who thrives in execution-focused environments while building leadership responsibilities over time. Responsibilities include oversight of EO sterilization processes, microbiological testing, sterility assurance, and risk assessment for manufacturing and product transfers. The role requires problem-solving under aggressive timelines, mentoring cross-functional teams, and managing vendor relationships to ensure high-quality outcomes. You will have the opportunity to contribute to a mission-driven organization while shaping processes critical to patient safety and product reliability.

• Own and oversee biocompatibility, sterility assurance, and microbial monitoring programs, including development, management, and execution
• Lead EO sterilization validations, re-qualifications, and repeatability studies with external sterilization providers
• Manage testing, validation, and documentation activities across bioburden, sterility, endotoxin, and EO residual programs
• Serve as the technical liaison to external labs and vendors, ensuring schedules, deliverables, and issue resolution
• Support manufacturing transfers, supplier changes, and alternate site qualifications from a sterility and microbiology perspective
• Partner with cross-functional teams on risk evaluations, technical assessments, and compliance initiatives
• Author, review, and approve protocols, reports, and documentation to meet ISO and FDA regulatory requirements

Requirements:

• Bachelor’s degree in Microbiology, Biology, Biomedical Engineering, or related scientific discipline
• 10+ years of hands-on experience in microbiology, biocompatibility, sterility assurance, or sterilization validation within the medical device industry
• Expertise with ISO 14937, ISO 11135, ISO 11737, ISO 10993, and FDA QMSR
• Practical experience with EO sterilization processes and external sterilization vendors
• Experience supporting Class II or III sterile medical devices
• Strong skills in cross-functional collaboration, technical documentation, and accountability for compliance and supply continuity
• Hands-on problem-solving mindset, able to execute against tight timelines in a growing organization
• Formal training in relevant ISO standards preferred
• Domestic travel up to 5%; hybrid work (4 days onsite, 1 day remote)

Benefits:

• Competitive base salary range of $180,000 - $220,000, plus variable incentives
• Stock options and opportunity for ownership in a mission-driven company
• Employee benefits including 401(k), healthcare insurance, and paid vacation
• Hybrid work flexibility
• Opportunities for personal and professional growth in a dynamic, collaborative environment
• Mentorship and team leadership opportunities

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

 Why Apply Through Jobgether? 

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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