Outset Medical
Senior Microbiologist
San Jose, CA · Senior
Sponsorship not specifiedDetected 64 days ago
Product ManagementFDA RegulatoryMedical DevicesCommunicationRegulatory Affairs
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Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Company Overview Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis.
- 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.
Responsibilities
- 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.
- 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.
- 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.
- Support internal, external, and regulatory audits as the microbiology subject-matter expert.
Requirements
- Bachelor's degree in microbiology, biology, biomedical engineering, or related scientific discipline.
- 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.
- Ability to interpret complex scientific data, identify risks, and make clear, evidence-based recommendations.
- Ability to operate effectively in a fast-paced environment with evolving priorities.
Benefits
- Support the development and validation of cleaning, disinfection, and microbial-control processes for medical devices and associated fluid pathways.
- 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.
Company info
- 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.
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This listing is sourced directly from Outset Medical's careers page and normalized into a canonical job model.