--- title: 'Senior Microbiologist​ at Outset Medical' canonical: 'https://feeny.ai/job/senior-microbiologist-outset-medical-san-jose-x25j77zb8tyc' type: 'job' last_seen: '2026-09-10' --- # Senior Microbiologist​ at Outset Medical - **Company:** Outset Medical - **Location:** San Jose, CA - **Compensation:** $112k–$152k - **Posted:** 2026-08-11 - **Last confirmed live:** 2026-09-10 - **Apply:** https://job-boards.greenhouse.io/outsetmedical/jobs/8694854002 ## Job description Company Overview Join 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. At 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. 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 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. Privacy is important to us. Please review our [Applicant Privacy Notice.](https://www.outsetmedical.com/wp-content/uploads/Applicant-Privacy-Notice.pdf) 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 peopleops@outsetmedical.com. ## EQUAL 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. ## About Outset Medical ## Core Business - **Primary industry**: Medical Equipment Manufacturing / Dialysis Technology - **Target customers**: Hospitals, health systems, dialysis clinics (B2B, enterprise) - **Mission or purpose statement**: “To give people their lives back” – enabling patients to fit dialysis into their life instead of fitting their life around dialysis. ## Products & Services - **Tablo Hemodialysis System**: A first-of-its-kind dialysis system that integrates water purification and on-demand dialysate production, eliminating the need for a dedicated water room. It serves as a single enterprise solution for acute, chronic, and home dialysis. (Hardware + Software) - **Outset Connect**: A data and analytics platform with seamless EMR integration that improves care and operational efficiency across the enterprise. (SaaS/Data Analytics) - **Insource with Outset**: A program that helps hospitals insource acute dialysis, including training, support, and enterprise deployment of Tablo. (Service) ## Market Standing - **Valuation/Market Cap**: Not publicly available in recent sources (stock price ~$3.85 as of mid-2026; market cap not explicitly stated) - **Key Metric**: Annual Revenue of $119.5M (latest fiscal year) - **Notable Investors/Partners**: Warburg Pincus (early backer), CRG (led $45M debt financing), Mubadala Capital Ventures (led $132M Series D), SLR Capital Partners ($300M post-IPO debt). IPO in September 2020. - **Growth Signals**: Nearly 1,000 hospitals and health systems have insourced acute dialysis with Outset; employee headcount of 368 (+2% YoY); active job postings across sales, engineering, and clinical roles; presence in Mexico and Philippines. ## Competitive Advantages - **Integrated water purification and on-demand dialysate production** – no water room needed, reducing infrastructure costs. - **Single enterprise solution** covering acute, chronic, and home dialysis – simplifies procurement and training. - **Clinical evidence** showing lower infection rates, fewer code blues, shorter ICU stays, and improved patient outcomes. - **Automated EMR integration** and a proprietary data analytics platform (Outset Connect) for better care coordination. - **Nurse training in under 4 hours**, enabling rapid adoption. ## Strategic Focus - Driving widespread adoption of Tablo across the care continuum, with a strong push to insource acute dialysis in hospitals. - Expanding into home hemodialysis to offer patients more flexibility and autonomy. - Continuing to build clinical evidence and operational efficiencies to lower total cost of care for providers. ## Why Work Here - **Culture**: Emphasizes curiosity, ingenuity, and conviction – “changing one of the largest, most expensive, and stagnant areas of healthcare.” - **Remote/Hybrid Policy**: Mixed – many roles are on-site (San Jose, Tijuana, field service across US), but some positions (e.g., Regional Lead, Clinical Excellence) are listed as remote. - **Growth Opportunities**: The company actively promotes internal mobility and provides “incredible growth opportunities” for current employees. - **Engineering & Technical Roles**: Active hiring in software (Android, SDET), hardware engineering, quality, and manufacturing – particularly in Tijuana, Mexico. - **Hiring Process**: Transparent 5-step process (recruiter phone → hiring manager → peer/team → talent activity → final with dept. head). No upfront payments or software installs required. - **Employee Ratings**: 3.9/5 on LinkedIn (228 reviews), with culture and compensation rated 4.0/5. ## Sources 1. [outsetmedical.com – About Us](https://www.outsetmedical.com/about-us/) 2. [outsetmedical.com – Homepage](https://www.outsetmedical.com/) 3. [outsetmedical.com – Careers](https://www.outsetmedical.com/opportunities/) 4. [Greenhouse – Jobs at Outset Medical](https://job-boards.greenhouse.io/outsetmedical) 5. [LinkedIn – Outset Medical Company Page](https://www.linkedin.com/company/outset-medical) ## Other roles at Outset Medical - [Field Service Engineer II (Sidney, OH)](https://feeny.ai/job/field-service-engineer-ii-sidney-oh-outset-medical-sidney-5sqsb45yrm0k) — Sidney, OH - [Clinical Excellence Manager - Las Vegas, NV.](https://feeny.ai/job/clinical-excellence-manager-las-vegas-nv-outset-medical-las-vegas-myqaxy7gc02b) — Las Vegas, NV - [Field Service Manager (Northeast)](https://feeny.ai/job/field-service-manager-northeast-outset-medical-united-states-northeast-t4sn5j1k8y53) — United States Northeast - [Clinical Excellence Manager (California)](https://feeny.ai/job/clinical-excellence-manager-california-outset-medical-remote-6vdq6hq4th2p) - [Field Service Engineer II (Seattle, WA)](https://feeny.ai/job/field-service-engineer-ii-seattle-wa-outset-medical-seattle-2sjttmnzbrhe) — Seattle, WA - [Field Service Engineer II (Longview, TX)](https://feeny.ai/job/field-service-engineer-ii-longview-tx-outset-medical-longview-avdnx3s5z3qb) — Longview, TX - [Field Service Engineer II (Freeport, IL)](https://feeny.ai/job/field-service-engineer-ii-freeport-il-outset-medical-freeport-svgjg3fr8qke) — Freeport, IL - [Director, Clinical Excellence](https://feeny.ai/job/director-clinical-excellence-outset-medical-remote-p4nz8rs3yxc6) - [Field Service Manager (Pacific Northwest)](https://feeny.ai/job/field-service-manager-pacific-northwest-outset-medical-pacific-northwest-tbfdjvmcq664) — Pacific Northwest, United States - [Clinical Excellence Manager](https://feeny.ai/job/clinical-excellence-manager-outset-medical-denver-colorado-salt-lake-city-kcagv8y57b64) — Denver Colorado & Salt Lake City, UT