Medical Device Reliability and Design Engineer

Tunnell Government Services•Bethesda, MD

23h•Onsite

About The Position

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. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.

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 experience with Design Control, Quality Systems Management, and ISO 13485 principles is essential
Must be a US Citizen or Full Green Card holder.

Nice To Haves

Working familiarity with FDA current Good Manufacturing Practices (cGMP) is a plus.

Responsibilities

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.
Review and give expert analysis regarding documents generated by BARDA contractors and federal employees for scientific / technical correctness and regulatory compliance. These include reviewing 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.
Where/when required, 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 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