Senior Microbiologist - Microbial Safety & Strategy

Outset Medical, Inc.; San Jose (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Outset Medical, Inc. is seeking a Senior Microbiologist to serve as the microbiology subject-matter expert across the product lifecycle. This hands-on role will develop strategies, lead testing and risk assessments, and ensure regulatory and quality compliance.

You will collaborate with R&D, Quality, Regulatory, Operations, Service, and external labs, influencing product quality and patient safety while mentoring teams and supporting audits and design controls.

Qualifications

• Bachelor’s degree in microbiology, biology, biomedical engineering, or related scientific discipline.
• Eight+ years in microbiology, with 5+ years in regulated healthcare industries.
• Strong knowledge of medical-device microbiology, microbial-control principles, test-method development and validation.
• Experience with bioburden, endotoxin, microbial identification, water-system microbiology, cleaning and disinfection.
• Working knowledge of FDA QSR, ISO 13485, quality risk management, and USP/ASTM/ISO standards.
• Proven ability to write and review technical protocols, reports, investigations, and regulatory docs.
• Ability to interpret complex data, identify risk, and make evidence-based recommendations.
• Cross-functional communication and project management skills.
• Ability to operate in a fast-paced environment with evolving priorities.

Responsibilities

• Lead microbiological risk assessments for products, processes, materials, and changes.
• Develop and execute strategies for microbiological testing across the lifecycle.
• Establish acceptance criteria, sampling plans, and test methods for bioburden and endotoxins.
• Review and author protocols, reports, and regulatory submission content.
• Qualify external microbiology labs and participate in audits for regulatory conformance.
• Provide microbiology expertise for design controls, CAPAs, and supplier issues.

Skills

Microbiology expertise

Regulatory knowledge

Cross-functional collaboration

Project management

Data interpretation

Education

Bachelor's degree in microbiology, biology, biomedical engineering, or related field

Master's or PhD preferred

Job description

Outset Medical, Inc. is seeking a Senior Microbiologist to serve as the microbiology subject-matter expert across the product lifecycle. This hands-on role will develop strategies, lead testing and risk assessments, and ensure regulatory and quality compliance.

You will collaborate with R&D, Quality, Regulatory, Operations, Service, and external labs, influencing product quality and patient safety while mentoring teams and supporting audits and design controls.