Medical Device Reliability and Design Engineer

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals.

About the role

Serve as a scientific and technical representative to the DHHS Contracting Officer (CO) and Program Officer (PO) (or COTR, as applicable) concerning IVD product development spanning:

• Advanced development, development, verification, and validation under a Quality Management System
• Regulatory filings and processes leading to FDA clearance
• Reliable, robust, and scalable commercial manufacturing

Responsibilities

• Review and give expert analysis regarding documents generated by BARDA contractors and federal employees for scientific/technical correctness and regulatory compliance, including design documents such as requirements, project plans, usability reports, design for manufacturing considerations, project risk analysis, product hazard analysis, and others.
• Render technical/regulatory compliance opinions to the PO/CO/COTR.
• Actively participate in meetings with federal and contractor employees to obtain and evaluate project status and progress against contract milestones.
• Perform site visits with PO/CO (COTR or other designated representative) to contractor facilities and/or facilities of subcontractors to verify compliance with contract requirements, federal regulations, and guidelines.
• Inform PO/CO/COTR of any increase/decrease in risk to the success of the project and generate contingency risk reduction plans.
• Prepare draft statements of work (SOW)/statements of objectives (SOO) for Requests for Proposals (RFP).
• Assist in contract negotiations on scientific/technical matters as requested, including reviewing proposed SOW.
• Use extensive technical and industry knowledge to provide insight and technical counsel concerning BARDA’s strategic position within the medical device/diagnostics developmental and manufacturing communities.
• Independently perform activities consistent with established organizational practices, precedents, policies, and strategic objectives set forth by BARDA management.
• Review incoming white papers and proposals.

Requirements

• A Masters or equivalent in mechanical, electrical, systems, biomedical engineering, or closely related scientific disciplines is required.
• 15 or more years of industry experience in one or more of the following areas:
  • IVD product development, with specific experience and accomplishments in diagnostics testing, from concept through commercialization
  • FDA diagnostic and medical device clearances, approvals, and licensures
  • Diagnostic device development expertise
  • Design and development of both instruments and cartridges
  • Microfluidic design, development, and troubleshooting
  • Plastics engineering/design for molding, specifically for cartridges
• The successful candidate may have government and/or academic accomplishments, but those are secondary to actual IVD industry experience.
• Substantial IVD advanced development skills should be demonstrable. Substantial skills in IVD process manufacturing should be demonstrable.
• Working familiarity with FDA current Good Manufacturing Practices (cGMP) is a plus.
• Working experience with Design Control, Quality Systems Management, and ISO 13485 principles is essential.
• Travel Requirements: up to 10%
• Must be a US Citizen or Full Green Card holder.