Staff Microbiologist

Stryker Group; San Jose (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

Stryker is seeking a Staff Microbiologist for the Endoscopy business unit in San Jose, CA. You will provide technical microbiology expertise across development, validation, and lifecycle management of medical devices, ensuring safety and regulatory compliance.

You will lead testing strategies, collaborate with cross-functional teams, and contribute to risk-based decisions throughout the product lifecycle to support quality and patient safety.

Qualifications

• Bachelor’s degree in biology, microbiology, biomedical engineering, toxicology, or related field.
• Minimum 4 years in medical device or regulated healthcare environments.
• Knowledge of ISO 10993, ISO 11135, ISO 11137, ISO 17665, AAMI, FDA, EU MDR and related standards.
• Experience drafting BEP/BER, test plans, validation protocols and reports.

Responsibilities

• Develop microbiology, biocompatibility, sterilization and reprocessing test strategies for medical devices.
• Lead microbiology and biocompatibility activities for product development projects; define testing requirements and validation strategies.
• Collaborate with R&D to provide technical guidance on materials, design, sterilization, and reprocessing.
• Prepare and review protocols, reports, risk assessments and regulatory documentation.
• Support audits, CAPAs, regulatory submissions, and supplier changes.

Skills

Microbiology

Biology

Sterilization

Biocompatibility

Education

Bachelor’s degree in biology, microbiology, biomedical engineering, toxicology, or related

Job description

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.

What you will do

• 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.

Preferred Qualifications:

• 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.

• Experience supporting regulatory submissions for global markets.

United States of America Pay Ranges:

• Puerto Rico: $77,700 - $129,500 USD Annual
• USN: $83,300 - $138,800 USD Annual
• US5: $87,500 - $145,700 USD Annual
• US10: $91,600 - $152,700 USD Annual
• US15: $95,800 - $159,600 USD Annual
• US20: $100,000 - $166,600 USD Annual
• US30: $108,300 - $180,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.