Senior Microbiologist, Medical Devices & Microbial Safety

Outset Medical; San Jose (CA); On-site; USD 112,000 - 152,000; Full time

Job summary

Outset Medical in the San Francisco Bay Area is seeking a Senior Microbiologist to lead microbiology strategy across the product lifecycle. You will drive testing, risk assessments, and regulatory-aligned quality controls to safeguard patient safety.

The role requires deep technical expertise, collaboration with R&D, Regulatory, Operations and external labs, and hands-on leadership in a fast-paced medical-device environment.

Qualifications

• Bachelor’s degree in microbiology, biology, biomedical engineering, or a related scientific discipline.
• Eight or more years of relevant microbiology experience in regulated healthcare industries.
• Strong knowledge of medical-device microbiology and test-method development.
• Experience with bioburden, endotoxin, microbial identification, water quality, cleaning and disinfection.
• Working knowledge of FDA QSR, ISO 13485, USP, AAMI, ASTM, or ISO standards.
• Experience writing technical protocols, reports, investigations, and regulatory documents.
• Ability to interpret complex data, identify risks, and make evidence-based recommendations.

Responsibilities

• Serve as the subject-matter expert for microbiology, microbial control, disinfection, and contamination risk.
• Develop microbiological strategies supporting product development, manufacturing, and post-market activities.
• Lead microbiological risk assessments for products, processes, and changes.
• Establish acceptance criteria, sampling plans, and test methods for bioburden and endotoxins.
• Support development/validation of cleaning and disinfection for medical devices.
• Author and review protocols, reports, and regulatory submission content.
• Evaluate test results and lead investigations and CAPAs.
• Mentor colleagues and collaborate across R&D, Quality, Regulatory, and Operations.

Skills

Microbiology

Molecular biology

Regulatory knowledge

Cross-functional communication

Project management

GxP experience

Education

Bachelor’s degree in microbiology or related field

Master’s degree (preferred)

PhD (desired)

Tools

Bioburden testing

Endotoxin testing

Water-system microbiology

Job description

Outset Medical in the San Francisco Bay Area is seeking a Senior Microbiologist to lead microbiology strategy across the product lifecycle. You will drive testing, risk assessments, and regulatory-aligned quality controls to safeguard patient safety.

The role requires deep technical expertise, collaboration with R&D, Regulatory, Operations and external labs, and hands-on leadership in a fast-paced medical-device environment.