Senior Microbiologist

Outset Medical, Inc.; San Jose (CA); Presencial; USD 140.000 - 200.000; Jornada completa

Descripción de la vacante

Outset Medical, Inc. is seeking a Senior Microbiologist to serve as the microbiology subject-matter expert across the product lifecycle. This hands-on role will develop strategies, lead testing and risk assessments, and ensure regulatory and quality compliance.

You will collaborate with R&D, Quality, Regulatory, Operations, Service, and external labs, influencing product quality and patient safety while mentoring teams and supporting audits and design controls.

Formación

• Bachelor’s degree in microbiology, biology, biomedical engineering, or related scientific discipline.
• Eight+ years in microbiology, with 5+ years in regulated healthcare industries.
• Strong knowledge of medical-device microbiology, microbial-control principles, test-method development and validation.
• Experience with bioburden, endotoxin, microbial identification, water-system microbiology, cleaning and disinfection.
• Working knowledge of FDA QSR, ISO 13485, quality risk management, and USP/ASTM/ISO standards.
• Proven ability to write and review technical protocols, reports, investigations, and regulatory docs.
• Ability to interpret complex data, identify risk, and make evidence-based recommendations.
• Cross-functional communication and project management skills.
• Ability to operate in a fast-paced environment with evolving priorities.

Responsabilidades

• Lead microbiological risk assessments for products, processes, materials, and changes.
• Develop and execute strategies for microbiological testing across the lifecycle.
• Establish acceptance criteria, sampling plans, and test methods for bioburden and endotoxins.
• Review and author protocols, reports, and regulatory submission content.
• Qualify external microbiology labs and participate in audits for regulatory conformance.
• Provide microbiology expertise for design controls, CAPAs, and supplier issues.

Conocimientos

Microbiology expertise

Regulatory knowledge

Cross-functional collaboration

Project management

Data interpretation

Educación

Bachelor's degree in microbiology, biology, biomedical engineering, or related field

Master's or PhD preferred

Descripción del empleo

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