Senior Microbiologist

Position Overview

The Senior Microbiologist will serve as a subject-matter expert for microbiological safety across the product lifecycle. This role will develop microbiological strategies, lead testing and risk assessments, support product and process changes, and ensure compliance with applicable regulatory and quality requirements. The ideal candidate combines deep technical expertise with a practical, risk-based approach and can work effectively across R&D, Quality, Regulatory, Operations, Service, and external laboratories. This is a hands-on role with significant influence on product quality and patient safety.

Essential Job Functions and Responsibilities

• Serve as the company's subject-matter expert for microbiology, microbial control, disinfection, and contamination risk.
• Develop and execute microbiological strategies supporting product development, manufacturing, sustaining engineering, and post-market activities.
• Lead microbiological risk assessments for products, processes, materials, manufacturing environments, and product or process changes.
• Establish acceptance criteria, sampling plans, and test methods for bioburden, bacterial endotoxins, microbial identification, water quality, and other microbiological evaluations.
• Support the development and validation of cleaning, disinfection, and microbial-control processes for medical devices and associated fluid pathways.
• Author and review protocols, reports, specifications, procedures, technical assessments, and regulatory submission content.
• Evaluate microbiological test results, including customer-obtained data, trends, deviations, and out-of-specification findings; lead or support investigations and corrective actions.
• Provide microbiology expertise for design controls, hazard analyses, change controls, nonconformances, CAPAs, complaints, and supplier issues.
• Qualify and oversee external microbiology laboratories, including review of methods, protocols, data, and technical reports, and participate in laboratory audits to evaluate conformance to company and regulatory requirements.
• Assess the microbiological impact of supplier, material, manufacturing, and design changes.
• Partner with Regulatory Affairs to address microbiology-related questions from regulatory agencies and notified bodies.
• Monitor changes in applicable regulations, standards, and scientific practices and translate them into practical company requirements.
• Mentor colleagues and strengthen microbiological knowledge across the organization.
• Support internal, external, and regulatory audits as the microbiology subject-matter expert.

Required Qualifications

• Bachelor's degree in microbiology, biology, biomedical engineering, or related scientific discipline.
• Eight or more years of relevant microbiology experience, including at least five years in the 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, as well as recognized published guidance.
• Demonstrated experience writing and reviewing technical protocols, reports, investigations, risk assessments, and regulatory documentation.
• Ability to interpret complex scientific data, identify risks, and make clear, evidence-based recommendations.
• Strong cross-functional communication and project-management skills.
• Ability to operate effectively in a fast-paced environment with evolving priorities.

Desired Qualifications.

• 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 incorporating automated cleaning or 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.

Key Competencies

• Technical and scientific judgment
• Patient- and product-safety mindset
• Ownership and accountability
• Structured problem-solving
• Clear and influential communication
• Cross-functional collaboration
• Comfort working both strategically and hands-on

Pay and benefits

SF Bay Area Salary Range $112,000—$152,000 USD

Company Culture

At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we've designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career.

An opportunity at Outset Medical won't just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams.

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Important Notice

We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note, Outset Medical will never request payment or gift cards during the hiring process, nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in @outsetmedical.cc, is not a legitimate Outset representative. For legitimate opportunities, always apply directly through our official careers page. If you are unsure about the authenticity of a communication, contact us immediately at.