Senior Staff Biocompatibility Scientist

Stryker Corporation • Tempe, AZ

40d • Hybrid

About The Position

Stryker is hiring a Senior Staff Biocompatibility Scientist for our Sustainability Solutions team within the Endoscopy division. In this role, you'll lead biological safety strategies for new and reprocessed medical devices, serving as the biocompatibility subject matter expert. You'll translate regulatory requirements and scientific data into actionable plans that ensure compliance and accelerate product development. This position involves strategic collaboration across QA, RA, R&D, and PMO to drive design decisions and bring innovative, sustainable solutions to market. Stryker's Sustainability Solutions (SSS) is committed to sustainable healthcare; changing the way healthcare thinks about "single-use" devices and extending the life through reprocessing. https://www.stryker.com/us/en/sustainability.html Workplace Flexibility: Candidate must reside within a commutable distance to Tempe, AZ but is expected to be onsite at the facility multiple times/week.

Requirements

• Bachelor's degree in Biology, Microbiology, Biomedical Engineering, or a closely related scientific field
• Minimum of 6+ years of relevant experience, including 4+ years leading technical biocompatibility projects in the medical device industry, with proven expertise in biological evaluation per ISO 10993-1-covering material characterization, endpoint selection, and risk-based justification.
• Strong knowledge of microbiological principles, cleaning validation, and reprocessing requirements for both terminally sterile and reusable products.
• Proven ability to apply ISO, FDA, and related regulatory guidelines in product design, manufacturing, and development of strategic innovations.
• Expertise in authoring and reviewing technical documentation (e.g., BEPs, BERs, risk assessments, protocols, reports) with high scientific rigor.

Nice To Haves

• Advanced degree (M.S. or Ph.D. in a relevant scientific discipline (e.g., Biology, Microbiology, Biomedical Engineering, Chemistry, or Toxicology)
• Active membership in external professional groups such as AAMI, SOT, AORN, etc
• Proven ability to develop and optimize biological test strategies, including biocompatibility assessments aligned with ISO 10993 and country-specific regulations.
• Experience with biomaterials, microbiology, and sterility processes (e.g., Ethylene Oxide, Steam, Radiation, VHP), as well as endotoxin (LAL) and bioburden testing for medical devices.
• Skilled in managing biocompatibility testing with external laboratories.
• Experience working closely and coordinating sterilization activities with contract sterilizers, operations, sourcing, and regulatory teams.
• Strong project management capabilities, including detailed planning, task management, and defining deliverables.
• Prior exposure to reusable or reprocessed medical devices and sustainability-focused product design initiatives.

Responsibilities

• Author Biological Safety Documentation: Independently create Biological Safety Evaluations, Plans, and Reports in compliance with ISO 10993-1 and global regulatory standards.
• Design & Evaluate Testing Strategies: Develop and critically assess biocompatibility test plans, data, and special process validations for medical device cleaning and reprocessing.
• Risk-Based Change Assessment: Analyze material, process, and supplier changes to determine biological safety impact and implement cost-effective, scientifically justified strategies.
• Regulatory Expertise & Support: Provide expert input for regulatory submissions and respond to agency inquiries with clear, evidence-based rationale.
• Cross-Functional Collaboration: Partner with R&D, Quality, Manufacturing, Regulatory, and other teams to align strategies and deliver project milestones.
• External Representation & Standards Development: Represent the organization in AAMI, ISO, and corporate working groups to influence standards and best practices.
• Leadership & Mentorship: Serve as biocompatibility SME, mentor junior team members, and communicate complex concepts to diverse audiences, including senior leadership.
• Continuous Improvement & Innovation: Drive enhancements in procedures, policies, and systems to optimize biological safety and sustainability initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 5,001-10,000 employees