Medical Device Reliability and Design Engineer

Tunnell Government Services; Bethesda (MD); On-site; USD 180,000 - 240,000; Full time

Job summary

Tunnell Government Services seeks a senior engineering/regulatory leader to drive end-to-end IVD development, from concept through FDA clearance, under BARDA guidance. You will review technical and regulatory documents, provide expert opinions to government officials, and lead risk analysis, design controls and manufacturing considerations.

The role requires 15+ years in IVD and related fields, with strong knowledge of cGMP, ISO 13485, and regulatory filings.

Qualifications

• Masters in mechanical, electrical, systems, biomedical engineering or closely related discipline.
• 15+ years of industry experience in IVD product development and regulatory pathways.

Responsibilities

• Serve as scientific/regulatory representative to CO/PO/COTR on IVD development spanning advanced development, verification, validation, and manufacturing.
• Review BARDA contractor/federal documents for technical correctness and regulatory compliance.
• Provide technical/regulatory opinions to PO/CO/COTR and participate in meetings to assess progress against milestones.
• Perform site visits to verify compliance with contract requirements and FDA/regulatory guidelines.
• Draft statements of work and assist in contract negotiations on technical matters.
• Offer insights on BARDA strategy within the medical device/diagnostics space and maintain adherence to organizational policies.

Skills

IVD product development

FDA regulatory experience

Design Control

Quality Systems Management

ISO 13485

Regulatory compliance analysis

SOW/SOO drafting

Education

Masters in engineering or related field

Job description

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.