Senior Microbiologist​

The role

The Senior Microbiologist serves as a subject-matter expert for microbiological safety across the product lifecycle. This role develops microbiological strategies, leads testing and risk assessments, and ensures compliance with regulatory and quality requirements.

What you will do

• Serve as the company's subject-matter expert for microbiology, microbial control, disinfection, and contamination risk.
• Develop and execute microbiological strategies for product development, manufacturing, and post-market activities.
• Lead microbiological risk assessments for products, processes, materials, and manufacturing environments.
• Establish acceptance criteria, sampling plans, and test methods for bioburden, endotoxins, and microbial identification.
• Support the development and validation of cleaning, disinfection, and microbial-control processes.
• Author and review protocols, reports, specifications, procedures, and regulatory submission content.
• Evaluate microbiological test results and lead investigations or corrective actions.
• Provide microbiology expertise for design controls, hazard analyses, change controls, and CAPAs.
• Qualify and oversee external microbiology laboratories and participate in laboratory audits.
• Assess the microbiological impact of supplier, material, manufacturing, and design changes.

Required qualifications

• Bachelor's degree in microbiology, biology, biomedical engineering, or related scientific discipline.
• Eight or more years of relevant microbiology experience.
• At least five years in medical-device, pharmaceutical, biotechnology, or other regulated healthcare industries.
• Strong knowledge of medical-device microbiology, microbial-control principles, test-method development, and validation.
• Experience with bioburden, bacterial endotoxin, microbial identification, water-system microbiology, cleaning, and disinfection.
• Working knowledge of FDA Quality System requirements, ISO 13485, quality risk management, and applicable USP, AAMI, ASTM, or ISO standards.
• Demonstrated experience writing and reviewing technical protocols, reports, investigations, risk assessments, and regulatory documentation.
• Ability to interpret complex scientific data and make evidence-based recommendations.
• Strong cross-functional communication and project-management skills.
• Ability to operate effectively in a fast-paced environment with evolving priorities.

Nice to have

• Master's degree or Ph.D. in microbiology or a related scientific discipline.
• Experience with dialysis systems, reusable medical equipment, water treatment, fluid pathways, or devices with automated cleaning/disinfection cycles.
• Experience supporting FDA submissions, regulatory inspections, or responses to regulatory agencies.
• Experience qualifying and managing contract laboratories.
• Certification such as Specialist Microbiologist through the National Registry of Certified Microbiologists or an equivalent credential.
• Experience mentoring technical staff or leading cross-functional microbiology initiatives.

About the company

Outset Medical is a medical device company revolutionizing the field of dialysis with the Tablo Hemodialysis System. The company focuses on creating technology that reduces the cost and complexity of dialysis.