Senior Medical Device Reliability & IVD Design Engineer

Tunnell Government Services; Washington (District of Columbia); On-site; USD 180,000 - 240,000; Full time

Job summary

Tunnell Government Services, Inc. seeks a senior scientific/regulatory leader to guide IVD product development from concept through commercialization, interacting with BARDA and government contract officers to drive regulatory filings and manufacturing readiness.

The candidate should hold a Master’s in engineering and bring 15+ years in diagnostics, with strong FDA, Design Control, ISO 13485, and cGMP expertise. Travel up to 10% and U.S. citizenship or Green Card required.

Qualifications

• Masters degree in engineering or closely related field required.
• 15+ years in IVD/diagnostics product development and regulatory experience.
• Experience with FDA clearances/approvals and regulatory filings.
• Deep knowledge of Design Control, QMS, and ISO 13485.
• Experience with device design for manufacturing and molding in cartridges.
• Familiarity with cGMP and regulatory standards is a plus.

Responsibilities

• Serve as scientific/regulatory rep to DHHS CO/PO/COTR for IVD development.
• Review technical/regulatory documents for correctness and compliance.
• Render technical/regulatory opinions to PO/CO/COTR.
• Participate in meetings to assess status against milestones.
• Conduct site visits to verify contract requirements and compliance.
• Inform leadership of risk and draft contingency plans.
• Prepare draft SOW/SOO for RFPs and assist in negotiations.
• Provide insights on BARDA's position in the medical device sector.
• Review incoming white papers and proposals.

Skills

IVD product development

FDA regulatory knowledge

Design Control

Quality Systems Management

ISO 13485

Microfluidic design

Plastics engineering / molding

cGMP familiarity

Education

Master's degree in mechanical, electrical, systems, biomedical engineering, or closely related field

Job description

Tunnell Government Services, Inc. seeks a senior scientific/regulatory leader to guide IVD product development from concept through commercialization, interacting with BARDA and government contract officers to drive regulatory filings and manufacturing readiness.

The candidate should hold a Master’s in engineering and bring 15+ years in diagnostics, with strong FDA, Design Control, ISO 13485, and cGMP expertise. Travel up to 10% and U.S. citizenship or Green Card required.