Stryker Corporation

Staff Microbiologist

Stryker Corporation • $83K — $138K *
San Jose, CA 95123In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or related field.
  • Minimum 4 years of experience in medical device or regulated healthcare environments.
  • Knowledge of medical device regulations including ISO and FDA standards.
  • Experience in authoring and reviewing technical documentation related to biological evaluation and testing.

Responsibilities

  • Apply regulatory standards to create microbiology and sterilization strategies for devices.
  • Lead microbiology and biocompatibility in product development.
  • Partner with R&D to advise on materials and sterilization methods.
  • Develop and review protocols and documentation for regulatory compliance.
  • Support design reviews and regulatory submissions.
  • Execute sterilization process validations and microbiological monitoring programs.
  • Engage in cross-functional collaboration and training activities.

Benefits

  • Remote, hybrid, or onsite work flexibility.
  • Work on impactful medical device projects that enhance patient safety.
  • Opportunities for professional development and knowledge sharing.
  • Involvement in innovative and cross-functional projects within the organization.
Full Job Description
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.

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.

Travel Percentage: 10%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Healthcare
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ
SYK
* Ladders Estimates

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