Senior Microbiologist: Microbial Safety Leader

Outset-Medical; San Jose (CA); On-site; USD 112,000 - 152,000; Full time

Job summary

Outset Medical seeks a Senior Microbiologist to lead microbiological safety across the product lifecycle, developing strategies, guiding testing, and ensuring compliance with regulatory and quality requirements.

The role requires hands-on expertise in microbiology, disinfection, and bioburden management, with cross-functional collaboration across R&D, Quality, Regulatory, Operations, and service labs.

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 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 standards.
• 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.

Responsibilities

• Serve as microbiology subject-matter expert for microbiology, microbial control, disinfection, and contamination risk.
• Develop and execute microbiological strategies supporting product development and manufacturing.
• Lead microbiological risk assessments for products, processes, materials, and changes.
• Establish acceptance criteria, sampling plans, and test methods for bioburden and related analyses.
• Support development and validation of cleaning and microbial-control processes for medical devices.
• Author and review protocols, reports, specifications, procedures, and regulatory content.
• Evaluate microbiology data and lead investigations and corrective actions.
• Mentor colleagues and strengthen microbiological knowledge across the organization.

Education

Bachelor’s degree in microbiology, biology, biomedical engineering, or related scientific discipline

Master’s degree or Ph.D. in microbiology or related scientific discipline

Strong cross-functional communication and project-management skills

Ability to interpret complex scientific data, identify risks, and make evidence-based recommendations

Job description

Outset Medical seeks a Senior Microbiologist to lead microbiological safety across the product lifecycle, developing strategies, guiding testing, and ensuring compliance with regulatory and quality requirements.

The role requires hands-on expertise in microbiology, disinfection, and bioburden management, with cross-functional collaboration across R&D, Quality, Regulatory, Operations, and service labs.