Principal Scientist, Biocompatibility
GE HealthcareSalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, HealthcareIndustries
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
- Candidate must reside within a commutable distance to Tempe, AZ and be expected to be onsite at the facility multiple times/week
- 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
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
Skills
ISO 10993-1
Biocompatibility Testing
Biological Safety Evaluation
Medical Device Reprocessing
Risk Assessment
Regulatory Submissions
AAMI Standards
ISO Standards
Stryker
Develops and manufactures medical devices and equipment
About Stryker
Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.
Kalamazoo, MichiganHeadquarters
1941Year Founded
$423.3MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees