Stryker · 3 weeks ago
Senior Staff Biocompatibility Scientist
Tempe, AZ
Full-time
Hybrid
Senior Level, Lead/Staff
6+ years expStryker is hiring a Senior Staff Biocompatibility Scientist for their Sustainability Solutions team within the Endoscopy division. In this role, you will lead biological safety strategies for medical devices, ensuring compliance with regulatory standards while collaborating across various departments to drive innovative solutions.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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
Qualification
Required
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
Preferred
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
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase