Medical Device Reliability and Design Engineer

Tunnell Government Services; Washington (District of Columbia); On-site; USD 180,000 - 240,000; Full time

Job summary

Tunnell Government Services, Inc. seeks a senior scientific/regulatory leader to guide IVD product development from concept through commercialization, interacting with BARDA and government contract officers to drive regulatory filings and manufacturing readiness.

The candidate should hold a Master’s in engineering and bring 15+ years in diagnostics, with strong FDA, Design Control, ISO 13485, and cGMP expertise. Travel up to 10% and U.S. citizenship or Green Card required.

Qualifications

• Masters degree in engineering or closely related field required.
• 15+ years in IVD/diagnostics product development and regulatory experience.
• Experience with FDA clearances/approvals and regulatory filings.
• Deep knowledge of Design Control, QMS, and ISO 13485.
• Experience with device design for manufacturing and molding in cartridges.
• Familiarity with cGMP and regulatory standards is a plus.

Responsibilities

• Serve as scientific/regulatory rep to DHHS CO/PO/COTR for IVD development.
• Review technical/regulatory documents for correctness and compliance.
• Render technical/regulatory opinions to PO/CO/COTR.
• Participate in meetings to assess status against milestones.
• Conduct site visits to verify contract requirements and compliance.
• Inform leadership of risk and draft contingency plans.
• Prepare draft SOW/SOO for RFPs and assist in negotiations.
• Provide insights on BARDA's position in the medical device sector.
• Review incoming white papers and proposals.

Skills

IVD product development

FDA regulatory knowledge

Design Control

Quality Systems Management

ISO 13485

Microfluidic design

Plastics engineering / molding

cGMP familiarity

Education

Master's degree in mechanical, electrical, systems, biomedical engineering, or closely related field

Job description

Job Description

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.

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.

Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.