Senior Microbiologist, Laboratory

Company OverviewJoin us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day.  We’re impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We’re giving providers time back to focus on patient care. 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. 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; 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. 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.  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-onSF Bay Area Salary Range$112,000—$152,000 USDCompany CultureAt Outset, we believe every person matters. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers. 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. 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. If you are unsure about the authenticity of a communication, contact us immediately at View email address on click.appcast.io EMPLOYMENT OPPORTUNITY STATEMENT Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.