Staff Microbiologist for Medical Devices: Sterilization

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 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.