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Medical Devices Subject Matter Expert
at Tunnell Consulting
The successful candidate will be a Medical Devices subject matter expert, with significant in-vitro diagnostics (IVD) product development industry experience. He/she will provide scientific, technical, and product development advice to the Biomedical Advanced Research and Development Authority (BARDA). The scope entails supporting the advanced research, full development, regulatory filings and clearances, and commercial manufacturing and performance of laboratory-based and point-of-care diagnostic tests produced by test developers under contract to the U.S. government. Some emphasis on clinical diagnostics may also be required. The Diagnostics SME is expected to clearly communicate thoughts and ideas to senior government managers and serve as a reliable resource of technical and product development counsel, at the direction of the government. The candidate will provide an interface between the government operational staff (project officers and contract officers) and BARDA contractors (product developers). The candidate must exhibit an extraordinary degree of ingenuity, creativity and resourcefulness in the application and development of advanced biotechnologies, technical and scientific principles, theories, and concepts. This SME will apply those skill sets to aid the government in developing and acquiring effective laboratory-based, point-of-care, and in-home diagnostics that predict patient infection from Category A and B pathogens/agents. BARDA is a matrix organization that requires each member to contribute in his/her area of expertise. The candidate will be responsible for scientific/technical problem solving, data analyses, attending technical update meetings, reviewing design development documents and technical reports, and writing progress and final reports.
Duties & Responsibilities:
Serve as a scientific and technical representative to the DHHS Contracting Officer (CO) and Program Officer (PO) (or COTR, as applicable) concerning laboratory-based, quick response, point-of-care, and in-home IVD’s spanning:
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 Advanced Research and Development (AR&D) and Project Bioshield (PBS) 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
A Masters or equivalent in mechanical, 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 point-of-care, rapid-diagnostics testing, from concept through commercialization.
FDA diagnostic and medical device clearances, approvals, and licensures.
Diagnostic assay development
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
7 or more years experience meeting multiple milestones on fast-paced projects
Project Management Professional (PMP) certification would be a plus
Oversight of IVD products through all developmental phases
Ability to manage multiple device/diagnostics subcontractors
Good track record of on-time delivery for project milestones
Approximately 10% covering some limited travel to contractor developmental and manufacturing facilities (might include international travel).