Senior Microbiologist at Outset Medical

San Jose, CAFull-timeQuality Engineering (305)Posted about 2 months ago

About the Role

<div class="content-intro">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.</div>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  <ul> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Serve as the company’s subject-matter expert for microbiology, microbial control, disinfection, and contamination risk. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Develop and execute microbiological strategies supporting product development, manufacturing, sustaining engineering, and post-market activities. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Lead microbiological risk assessments for products, processes, materials, manufacturing environments, and product or process changes. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Establish acceptance criteria, sampling plans, and test methods for bioburden, bacterial endotoxins, microbial identification, water quality, and other microbiological evaluations. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Support the development and validation of cleaning, disinfection, and microbial-control processes for medical devices and associated fluid pathways. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Author and review protocols, reports, specifications, procedures, technical assessments, and regulatory submission content. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Evaluate microbiological test results, including customer-obtained data, trends, deviations, and out-of-specification findings; lead or support investigations and corrective actions. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Provide microbiology expertise for design controls, hazard analyses, change controls, nonconformances, CAPAs, complaints, and supplier issues. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">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. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Assess the microbiological impact of supplier, material, manufacturing, and design changes. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Partner with Regulatory Affairs to address microbiology-related questions from regulatory agencies and notified bodies. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Monitor changes in applicable regulations, standards, and scientific practices and translate them into practical company requirements. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Mentor colleagues and strengthen microbiological knowledge across the organization. </li> <li data-leveltext="•" data-font="Arial" data-listid="26" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":540,"469769226":"Arial","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Support internal, external, and regulatory audits as the microbiology subject-matter expert. </li> </ul> Required Qualifications    <ul> <li>Bachelor’s degree in microbiology, biology, biomedical engineering, or related scientific discipline.  </li> <li>Eight or more years of relevant microbiology experience, including at least five years in the medical-device, pharmaceutical, biotechnology, or other regulated healthcare industries.  </li> <li>Strong knowledge of medical-device microbiology, microbial-control principles, test-method development, and validation.  </li> <li>Experience with bioburden, bacterial endotoxin, microbial identification, water-system microbiology, cleaning, and disinfection.  </li> <li>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.  </li> <li>Demonstrated experience writing and reviewing technical protocols, reports, investigations, risk assessments, and regulatory documentation.  </li> <li>Ability to interpret complex scientific data, identify risks, and make clear, evidence-based recommendations.  </li> <li>Strong cross-functional communication and project-management skills.  </li> <li>Ability to operate effectively in a fast-paced environment with evolving priorities.  </li> </ul> Desired Qualifications.  <ul> <li>Master’s degree or Ph.D. in microbiology or a related scientific discipline.  </li> <li>Experience with dialysis systems, reusable medical equipment, water treatment, fluid pathways, or devices incorporating automated cleaning or disinfection cycles.  </li> <li>Experience supporting FDA submissions, regulatory inspections, or responses to regulatory agencies.  </li> <li>Experience qualifying and managing contract laboratories.  </li> <li>Certification such as Specialist Microbiologist through the National Registry of Certified Microbiologists or an equivalent credential.  </li> <li>Experience mentoring technical staff or leading cross-functional microbiology initiatives.  </li> </ul> Key Competencies   <ul> <li>Technical and scientific judgment  </li> <li>Patient- and product-safety mindset  </li> <li>Ownership and accountability  </li> <li>Structured problem-solving  </li> <li>Clear and influential communication  </li> <li>Cross-functional collaboration  </li> <li>Comfort working both strategically and hands-on</li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">SF Bay Area Salary Range</div><div class="pay-range">$112,000—$152,000 USD</div></div></div><div class="content-conclusion">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 <a href="https://www.outsetmedical.com/wp-content/uploads/Applicant-Privacy-Notice.pdf">Applicant Privacy Notice.</a>    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 <a href="mailto:[email protected]">[email protected]</a>.   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. </div>

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