Duties & 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
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.
