Staff Microbiologist

Stryker · San Jose, CA

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ResearchFull-time$78k–$130kCompany career page

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Role summary

Stryker's Endoscopy business unit seeks a Staff Microbiologist to lead technical activities in microbiology, sterilization, biocompatibility, and reprocessing for medical device development and lifecycle management. The role involves developing test strategies, managing validation efforts, and ensuring regulatory compliance across product portfolios in San Jose, California.

What they're looking for

Bachelor's degree in biology, microbiology, biomedical engineering, toxicology, or related scientific field
Minimum 4 years experience in medical device, pharmaceutical, or regulated healthcare microbiology or sterilization
Working knowledge of ISO 10993, ISO 11135, ISO 11137, ISO 17665, AAMI, FDA, and EU MDR standards
Experience authoring and reviewing technical documentation including protocols, validation plans, and biocompatibility reports
Master's degree or Ph.D. in relevant discipline (preferred)
Experience spanning reusable device processing, terminal sterilization, and biological safety evaluations (preferred)

What you'll be doing

Apply regulatory standards to develop microbiology, sterilization, and biocompatibility test strategies for medical devices
Lead microbiology and biocompatibility activities for product development projects, defining testing requirements and validation approaches
Provide technical guidance to R&D teams on materials, design, sterilization methods, and reprocessing considerations
Execute sterilization validations, equipment qualifications, and microbiological monitoring programs
Support regulatory submissions, design reviews, engineering changes, audits, and nonconformance investigations

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