Senior Microbiologist – Medical Devices

Advantage Technical; Saint Paul (MN); Sur place; USD 67 000 - 96 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Microbiology expertise

Risk assessments

Technical writing

Cross-functional collaboration

Regulatory compliance

Formation

Bachelor's degree in Microbiology

Description du poste

Position Type: Year Long Contract With Opportunity to Extend

Pay Rate: Up to $59.00 per hour (approximately $120,000 annually)

Travel: Approximately 10–20%

Work Authorization: Applicants must be authorized to work in the United States without current or future visa sponsorship. Sponsorship is not available for this position.

Position Overview

This company is seeking an experienced Senior Microbiologist to provide technical expertise and microbiological risk assessment support across medical device manufacturing, new product development, contract manufacturing, acquisitions, and quality system activities.

This individual will serve as a Microbiology Subject Matter Expert (SME), collaborating with Manufacturing, Quality Assurance, Supplier Quality, Regulatory Affairs, Research & Development (R&D), and external manufacturing partners to ensure product quality, patient safety, and regulatory compliance.

The ideal candidate will have a strong background in medical device microbiology, microbiological risk assessments, contamination control, technical documentation, and regulated manufacturing environments.

This position requires independent scientific judgment, strong technical writing skills, and the ability to evaluate microbiological risks associated with product changes, manufacturing processes, supplier activities, and quality investigations.

Key Responsibilities

Microbiology Technical Support & Risk Assessment

• Serve as a Microbiology SME supporting medical devices manufactured internally and through external contract manufacturing partners.
• Conduct microbiological risk assessments for medical devices, raw materials, manufacturing processes, facilities, suppliers, and product changes.
• Author, review, and approve, as authorized, Microbiology Evaluation Reports (MBERs), technical assessments, risk evaluations, and scientific documentation.
• Evaluate the microbiological impact of product design modifications, manufacturing process changes, material substitutions, supplier changes, and facility modifications.
• Provide technical recommendations based on scientific evidence, risk assessments, and applicable regulatory requirements.

Contract Manufacturing, Acquisitions & Product Transfers

• Provide microbiology expertise to support contract manufacturers, external suppliers, and manufacturing partners.
• Participate in acquisition due diligence activities, including microbiological risk evaluations and assessments of manufacturing and quality systems.
• Support manufacturing transfers, product integrations, and commercialization initiatives.
• Collaborate with cross-functional teams to identify and mitigate microbiological risks during product and process transitions.
• Evaluate microbiological controls and quality requirements associated with external manufacturing operations.

Quality Systems & Regulatory Compliance

• Support investigations, nonconformances, Corrective and Preventive Actions (CAPAs), and change control activities involving microbiological concerns.
• Assess microbiological risks associated with manufacturing deviations, contamination events, and quality issues.
• Provide technical expertise during internal audits, external audits, regulatory inspections, and inspection readiness activities.
• Support compliance with applicable FDA regulations, ISO 13485, and global medical device quality system requirements.
• Contribute to continuous improvement initiatives involving microbiological controls, quality processes, and risk management.

New Product Development & Cross-Functional Collaboration

• Provide microbiology support for new product development, design changes, product lifecycle management, and commercialization projects.
• Partner with R&D, Manufacturing, Quality, Supplier Quality, and Regulatory Affairs to evaluate microbiological requirements throughout the product lifecycle.
• Support assessments involving contamination control, environmental monitoring, bioburden, and sterilization-related considerations, as applicable.
• Communicate technical findings, microbiological risks, and recommended corrective actions to project teams and leadership.
• Manage multiple technical projects while maintaining accurate documentation and meeting established timelines.

Required Qualifications

• Bachelor's degree in Microbiology, Biology, Biomedical Sciences, or a related scientific discipline.
• Minimum of 5 years of experience in microbiology, quality, manufacturing, engineering, or related technical functions within a regulated industry.
• Experience conducting scientific evaluations, technical assessments, and risk-based analyses.
• Strong technical writing skills, including experience preparing scientific reports, risk assessments, and quality documentation.
• Ability to independently evaluate technical issues, develop recommendations, and support cross-functional decision-making.
• Experience working with multidisciplinary teams and managing multiple priorities.
• Strong analytical, organizational, problem-solving, and communication skills.

Preferred Qualifications

• Medical device industry experience strongly preferred.
• Experience supporting contract manufactured medical devices, suppliers, or external manufacturing partners.
• Experience performing microbiological risk assessments for medical devices, manufacturing processes, materials, or supplier changes.
• Experience authoring or reviewing Microbiology Evaluation Reports (MBERs) or comparable technical risk assessment documentation.
• Knowledge of bioburden testing, contamination control, environmental monitoring, sterilization processes, and microbiological quality requirements.
• Experience supporting CAPA investigations, nonconformances, deviations, and change control.
• Familiarity with FDA medical device regulations, ISO 13485, and applicable international quality standards.
• Experience supporting acquisitions, manufacturing transfers, product transfers, or new product development.
• Experience working with cross-functional teams across multiple manufacturing sites or geographic regions.
• Ability to present scientific findings and technical recommendations to leadership and project stakeholders.