Senior Microbiologist

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 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 industry. 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 risk, 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. Preferred 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. 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 #J-18808-Ljbffr Outset Medical, Inc.