Senior Microbiologist & Risk SME – Medical Devices

Advantage Technical; Saint Paul (MN); On-site; USD 67,000 - 96,000; Full time

Job summary

Advantage Technical is seeking an experienced Senior Microbiologist to provide microbiological risk assessments and SME support across medical device manufacturing, new product development, contract manufacturing, acquisitions, and quality system activities.

The ideal candidate will collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, and external manufacturing partners to ensure product quality, patient safety, and regulatory compliance.

Qualifications

• Bachelor's degree in Microbiology or related science.
• Minimum 5 years in microbiology/quality/manufacturing in regulated settings.
• Experience writing scientific reports and risk assessments.

Responsibilities

• Serve as Microbiology SME for medical devices, both in-house and with contract manufacturers.
• Conduct microbiological risk assessments on materials, processes, facilities and changes.
• Author and review Microbiology Evaluation Reports (MBERs) and related docs.
• Evaluate microbiological impact of design changes, process changes and supplier changes.
• Provide data-driven technical recommendations to meet regulatory requirements.

Skills

Microbiology expertise

Risk assessments

Technical writing

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in Microbiology

Job description

Advantage Technical is seeking an experienced Senior Microbiologist to provide microbiological risk assessments and SME support across medical device manufacturing, new product development, contract manufacturing, acquisitions, and quality system activities.

The ideal candidate will collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, and external manufacturing partners to ensure product quality, patient safety, and regulatory compliance.