{"id":266445,"url":"https://alion.io/job/outsetmedical-senior-microbiologist","title":"Senior Microbiologist","company":{"id":21109,"name":"Outset Medical","domain":"outsetmedical.com","url":"https://alion.io/company/outsetmedical","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":85,"open_postings":5,"ghost_share":0,"stale_share":0.4,"repost_share":0,"time_to_fill_p50_days":73,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Jose, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":112000,"max":152000,"currency":"USD","period":"year","gross":null,"usd_annual":152000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-08-11T17:59:34Z","employer_posted_date":"2026-08-20","last_verified_at":"2026-10-26T03:09:31Z","board_verified":true,"closed_at":null,"days_open":75,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":75},"description":"Company Overview\nJoin us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. 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. \nAt Outset we’re revolutionizing an industry and changing lives. 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. And we’re giving patients the power to take control of their life and get back to enjoying the things they love.\nPosition Overview \nThe 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 productand process changes, and ensure compliance with applicable regulatory and quality requirements. The ideal candidate combines deep technical expertisewith 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. \nEssential Job Functions and Responsibilities \nServe as the company’s subject-matter expert for microbiology, microbial control, disinfection, and contamination risk. \nDevelop and execute microbiological strategies supporting product development, manufacturing, sustaining engineering, and post-market activities. \nLead microbiological risk assessments for products, processes, materials, manufacturing environments, and product or process changes. \nEstablish acceptance criteria, sampling plans, and test methods for bioburden, bacterial endotoxins, microbial identification, water quality, and other microbiological evaluations. \nSupport the development and validation of cleaning, disinfection, and microbial-control processes for medical devices and associated fluid pathways. \nAuthor and review protocols, reports, specifications, procedures, technical assessments, and regulatory submission content. \nEvaluate microbiological test results, including customer-obtained data, trends, deviations, and out-of-specification findings; lead or support investigations and corrective actions. \nProvide microbiology expertise for design controls, hazard analyses, change controls, nonconformances, CAPAs, complaints, and supplier issues. \nQualify 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. \nAssess the microbiological impact of supplier, material, manufacturing, and design changes. \nPartner with Regulatory Affairs to address microbiology-related questions from regulatory agencies and notified bodies. \nMonitor changes in applicable regulations, standards, and scientific practices and translate them into practical company requirements. \nMentor colleagues and strengthen microbiological knowledge across the organization. \nSupport internal, external, and regulatory audits as the microbiology subject-matter expert. \nRequired Qualifications \nBachelor’s degree in microbiology, biology, biomedical engineering, or related scientific discipline. \nEight or more years of relevant microbiology experience, including at least five years in the medical-device, pharmaceutical, biotechnology, or other regulated healthcare industries. \nStrong knowledge of medical-device microbiology, microbial-control principles, test-method development, and validation. \nExperience with bioburden, bacterial endotoxin, microbial identification, water-system microbiology, cleaning, and disinfection. \nWorking 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. \nDemonstrated experience writing and reviewing technical protocols, reports, investigations, risk assessments, and regulatory documentation. \nAbility to interpret complex scientific data, identify risks, and make clear, evidence-based recommendations. \nStrong cross-functional communication and project-management skills. \nAbility to operate effectively in a fast-paced environment with evolving priorities. \nDesired Qualifications. \nMaster’s degree or Ph.D. in microbiology or a related scientific discipline. \nExperience with dialysis systems, reusable medical equipment, water treatment, fluid pathways, or devices incorporating automated cleaning or disinfection cycles. \nExperience supporting FDA submissions, regulatory inspections, or responses to regulatory agencies. \nExperience qualifying and managing contract laboratories. \nCertification such as Specialist Microbiologist through the National Registry of Certified Microbiologists or an equivalent credential. \nExperience mentoring technical staff or leading cross-functional microbiology initiatives. \nKey Competencies \nTechnical and scientific judgment \nPatient- and product-safety mindset \nOwnership and accountability \nStructured problem-solving \nClear and influential communication \nCross-functional collaboration \nComfort working both strategically and hands-on\nSF Bay Area Salary Range\n$112,000—$152,000 USD\nCompany Culture\nAt 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. \nWe 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. \nAn 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. \nPrivacy is important to us. Please review our Applicant Privacy Notice. \nImportant Notice\nWe 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 .\nEQUAL EMPLOYMENT OPPORTUNITY STATEMENT \nOutset 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. 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