Microbiologist, Medical Devices & Sterilization

PowerToFly; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Stryker in San Jose, CA seeks a Staff Microbiologist to support development, validation, and lifecycle management of medical devices. You will lead microbiology, biocompatibility, and sterilization activities across NPD and sustaining engineering projects, ensuring biological safety and regulatory compliance.

Responsibilities include developing testing strategies, authoring BEP/BER and technical reports, and collaborating with R&D, Regulatory Affairs, Quality, Manufacturing, and suppliers.

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.

Responsibilities

• 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.

Skills

Microbiology

Regulatory standards knowledge

Technical documentation

Cross-functional collaboration

Education

Bachelor's degree in biology/related

Master's or PhD in related field

Job description

Stryker in San Jose, CA seeks a Staff Microbiologist to support development, validation, and lifecycle management of medical devices. You will lead microbiology, biocompatibility, and sterilization activities across NPD and sustaining engineering projects, ensuring biological safety and regulatory compliance.

Responsibilities include developing testing strategies, authoring BEP/BER and technical reports, and collaborating with R&D, Regulatory Affairs, Quality, Manufacturing, and suppliers.