Staff Microbiologist, Medical Devices & Sterilization

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 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