Staff Microbiologist

Work Flexibility: Remote or Hybrid or Onsite Stryker is seeking a Staff Microbiologist for our Endoscopy business unit in San Jose, CA. We are seeking a talented and motivated Microbiologist to provide technical expertise supporting the development, validation, and lifecycle management of medical devices. In this role, you will partner with cross-functional teams to support microbiology, sterilization, reprocessing, and biocompatibility activities for both new product development and sustaining engineering efforts. You will independently lead assigned projects, develop technical strategies, and ensure products meet applicable biological safety, sterilization, and regulatory requirements. This position plays a key role in supporting product quality, regulatory compliance, and patient safety through the application of scientific principles, industry standards, and risk-based decision making throughout the product lifecycle.

Apply ISO, FDA, AAMI, EU MDR, and other applicable standards to develop microbiology, biocompatibility, sterilization, and reprocessing test strategies for medical devices. Lead microbiology and biocompatibility activities for product development projects, including defining testing requirements, acceptance criteria, and validation strategies. Partner with R&D teams to provide technical guidance on materials, product design, sterilization methods, and reprocessing considerations throughout development. Develop, review, and approve protocols, reports, risk assessments, and technical documentation supporting biological safety, sterilization, processing, and regulatory compliance. Support design reviews, development milestones, engineering changes, supplier changes, nonconformance investigations, CAPAs, and regulatory submissions. Execute and support sterilization process validations, equipment qualifications (IQ/OQ/PQ), requalification activities, and microbiological monitoring programs. Assess technical risks and recommend solutions to ensure product safety, performance, compliance, and successful project execution. Participate in regulatory and supplier audits as a subject matter expert for microbiology, sterilization, biocompatibility, and reprocessing activities. Contribute to the development and continuous improvement of procedures, work instructions, and processes to align with evolving regulations and industry standards. Support knowledge sharing and onboarding activities by providing technical guidance and training to team members and cross-functional partners. Collaborate with cross-functional teams including R&D, Regulatory Affairs, Quality, Manufacturing, Operations, and external testing laboratories. What you need Required Qualifications: Bachelor’s degree in biology, Microbiology, Biomedical Engineering, Toxicology, or a related scientific discipline. Minimum 4 years of experience in medical device, pharmaceutical, biotechnology, or regulated healthcare environments supporting microbiology, biocompatibility, sterilization, processing, or sterility assurance activities for sterile and/or reusable products. Working knowledge of medical device regulations such as ISO 10993, ISO 11135, ISO 11137, ISO 17665, AAMI, FDA, EU MDR, and other applicable regulatory standards. Experience authoring and reviewing technical documentation, including biological evaluation plans/reports (BEP/BER), test plans, validation protocols, validation documentation, and technical reports.

Master's degree or Ph.D. in Biology, Microbiology, Biomedical Engineering, Toxicology, Chemistry, or a related scientific discipline. Experience spanning all three key technical disciplines: reusable medical device processing validations, terminal sterilization technologies, and biological testing strategy development and biological safety evaluations. Experience working with external test laboratories, contract sterilizers, and suppliers supporting biological safety or sterilization activities.