IVD Reliability & Design Engineer (Reg & Manufacturing)

Tunnell Government Services, Inc.; Bethesda (MD); On-site; USD 180,000 - 240,000; Full time

Job summary

Tunnell Government Services, Inc. is seeking a senior scientific/technical lead for IVD product development, regulatory compliance, and quality systems management. The role involves working with BARDA and federal teams to ensure regulatory filings and successful manufacturing readiness.

Ideal candidates will have 15+ years in IVD diagnostics, FDA clearances, and design control, with experience in vendor and contract oversight and a strong regulatory mindset. Travel up to 10% may be required.

Qualifications

• Masters or equivalent in mechanical, electrical, systems, biomedical engineering, or closely related scientific disciplines is required.
• 15+ years of industry experience in IVD product development, diagnostics testing from concept through commercialization, and regulatory filings.

Responsibilities

• Serve as a scientific/technical representative to CO/PO/COTR on IVD product development, including advanced development and QMS-based validation.
• Review documents for technical correctness and regulatory compliance across design docs, risk analyses, and usability reports.
• Render regulatory opinions to PO/CO/COTR and participate in meetings to assess status and milestones.
• Perform site visits to verify contract compliance and support contingency risk planning.
• Assist in drafting SOW/SOO for RFPs and support contract negotiations on technical matters.

Skills

IVD product development

Regulatory compliance

FDA regulatory experience

Design Control

Education

Master's degree in engineering

Job description

Tunnell Government Services, Inc. is seeking a senior scientific/technical lead for IVD product development, regulatory compliance, and quality systems management. The role involves working with BARDA and federal teams to ensure regulatory filings and successful manufacturing readiness.

Ideal candidates will have 15+ years in IVD diagnostics, FDA clearances, and design control, with experience in vendor and contract oversight and a strong regulatory mindset. Travel up to 10% may be required.