Staff Microbiologist

Stryker; San Jose (CA); On-site; USD 90,000 - 160,000; Full time

Job summary

Stryker is seeking a Staff Microbiologist for the Endoscopy business unit in San Jose, CA. You will provide technical expertise across microbiology, biocompatibility, sterilization, and reprocessing for new product development and sustaining engineering.

You will lead projects, shape strategies, and ensure regulatory and safety requirements are met throughout the product lifecycle. Collaborating with cross-functional teams, you will contribute to quality, regulatory compliance, and patient

Qualifications

• Bachelor’s degree in biology, microbiology, biomedical engineering, toxicology, or related field.
• Minimum 4 years in medical device/regulated healthcare environments supporting microbiology, biocompatibility, sterilization, processing, or sterility assurance.

Responsibilities

• Apply ISO, FDA, AAMI, EU MDR, and other standards to develop test strategies for microbiology, biocompatibility, sterilization and reprocessing.
• Lead microbiology and biocompatibility activities for product development projects with testing requirements and validation strategies.
• Provide technical guidance on materials, design, sterilization methods, and reprocessing considerations.
• Develop, review, and approve protocols, reports, risk assessments, and documentation for biological safety and regulatory compliance.

Skills

Microbiology

Regulatory knowledge

Technical documentation

Test method development

Education

Bachelor’s degree in biology / microbiology / related field

Master’s or Ph.D. preferred

Tools

BEP/BER

Validation protocols

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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.