Staff Biocompatibility Scientist

Stryker • Greenwood Village, CO

2d • $91,600 - $152,700 • Hybrid

About The Position

Stryker’s Sports Medicine division is hiring a Staff Biocompatibility Scientist to provide technical expertise in biocompatibility, biological safety, and medical device microbiology across new product development and sustaining projects. The role leads biological evaluations, risk assessments, and testing strategies for complex medical devices, while supporting sterilization, device cleanliness, bacterial endotoxin, and reusable device processing. The successful candidate applies expertise in ISO 10993-1:2025, quality systems, and design controls, and partners cross-functionally to support patient safety and global regulatory submissions.

This hybrid role requires the candidate to be within commuting distance of Greenwood Village, Colorado. In-office presence is required three days per week, with remote work available the rest of the week. Candidates must be able to commute to the facility as needed. Travel is 10%.

Requirements

• Bachelor’s degree in microbiology, biology, chemistry, toxicology, biomedical engineering, or a closely related scientific discipline.
• Minimum of 4 years of relevant experience, including at least 2 years independently leading technical biocompatibility projects in the medical device industry.
• Demonstrated experience applying ISO 10993-1:2025 and applicable ISO 10993 standards to biological evaluations, risk assessments, test strategies, and technical reports.
• Experience evaluating material and process information, chemical characterization, toxicological risk assessments, scientific literature, and biological test data to support biological safety conclusions.
• Experience assessing the impact of sterilization, manufacturing cleanliness, EO residuals, and/or reusable device processing on medical device biological safety.
• Experience working within medical device quality systems, including design controls and change control, to support technical assessments and documentation.

Nice To Haves

• Experience supporting FDA submissions, EU MDR technical documentation, notified body reviews, or other global regulatory submissions.
• Experience participating in regulatory inspections or supplier audits involving cleanroom or sterilization processes.

Responsibilities

• Independently develop, author, and maintain biological evaluation strategies, plans, reports, and risk assessments for implantable, non-implantable, single-use, and reusable medical devices in accordance with ISO 10993-1:2025 and ISO 14971.
• Apply ISO 10993-1:2025 to identify biological hazards, estimate and evaluate biological risks, establish risk controls, and assess residual risk throughout the medical device lifecycle.
• Critically evaluate material and process information, chemical characterization, toxicological risk assessments, literature, and biological test data to identify evidence gaps, determine testing needs, and document scientifically justified conclusions.
• Assess product, material, supplier, manufacturing, cleaning, packaging, sterilization, and lifecycle changes for biological safety and microbiological impact, including biological equivalence and required validation activities.
• Independently plan and execute assigned microbiology activities, including test plans, sampling strategies, acceptance criteria, and evaluation of bioburden, sterility, bacterial endotoxin, ethylene oxide/ethylene chlorohydrin residuals, and contamination control data.
• Develop and evaluate cleaning, disinfection, and sterilization validation strategies for assigned devices, including the effects of repeated processing on device cleanliness and biological safety.
• Coordinate external laboratory studies by defining study scope and test article selection, reviewing protocols, resolving technical issues, and critically evaluating final reports.
• Monitor applicable standards and regulatory guidance, perform gap and product-impact assessments, implement approved documentation updates, and prepare technical responses to regulatory authorities and notified bodies in partnership with Regulatory Affairs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior