Project Manager/Product Engineer
Listed on 2026-10-20
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Engineering
Quality Engineering, Test Engineer, Biomedical Engineer, Medical Device Industry
Dilon Technologies | Engineering| Full-time | On-site
About Dilon Technologies
Dilon Technologies is an innovative medical device company headquartered in Newport News, Virginia, dedicated to advancing breast health through cutting-edge medical technologies. With a focus on improving patient outcomes, Dilon develops and commercializes solutions that support healthcare professionals in the detection, diagnosis, and treatment of breast cancer.
Our product portfolio includes Margin Probe, Navigator, and True View, technologies designed to enhance surgical precision, improve clinical decision-making, and support quality patient care.
At Dilon, we are committed to innovation, collaboration, and continuous improvement. Our team offers employees the opportunity to work in a dynamic, hands‑on environment where individual contributions make a meaningful difference.
Our mission is to provide innovative medical technologies that empower healthcare professionals and improve the lives of patients.
About the RoleDilon Technologies is looking for a Product / Project Engineer to help take our next‑generation medical devices from concept through production. You’ll work directly with the VP of Engineering to turn product ideas into clear requirements, keep development projects on track, and write the design documentation and V&V protocols that get products through design controls.
This is a hands‑on, cross‑functional role on a small engineering team. You’ll work with hardware, software, mechanical/manufacturing, and test engineers every day, and you’ll get broad exposure to the whole product lifecycle. It’s a strong fit for an engineer who likes seeing how all the pieces fit together and wants to grow toward systems engineering or project leadership.
What You’ll Do- Requirements: Work with the team to translate user needs and product goals into clear, testable product and subsystem requirements.
- Project coordination: Plan and track development projects: build schedules, track tasks and action items, flag risks early, and keep work moving across disciplines.
- V&V protocols: Write V&V plans and protocols with clear acceptance criteria and traceability to requirements and risk controls.
- Testing and reporting: Coordinate test execution with our test engineer/technician and external test labs; write test reports and document deviations.
- Traceability: Maintain requirements traceability from user needs through design inputs, outputs, risk controls, and verification evidence.
- Risk management: Create risk management files per ISO 14971, including hazard analyses and FMEAs.
- Design controls: Build and maintain DHF content, prepare design review packages, and help turn engineering work into clear, compliant documentation.
- Standards testing: Help plan and coordinate testing to standards such as IEC 60601-1 and IEC 60601-1‑2, including scheduling and working with external test labs.
- Change and investigations: Support ECOs, anomaly investigations, and CAPAs, including impact assessments and documentation.
- Design transfer: Support design transfer with manufacturing engineering, including pilot builds and production readiness.
- Communication: Serve as a day‑to‑day point of contact for suppliers, contract partners, and internal teams on project status and technical questions.
- Bachelor’s degree in engineering (any discipline: Electrical, Mechanical, Biomedical, Systems, or related).
- [2–5] years of engineering experience, preferably in medical devices or another regulated industry.
- Exposure to design controls (21 CFR 820 / ISO 13485) and risk management (ISO 14971).
- Experience writing technical documents such as test protocols, test reports, or requirements.
- Strong technical writing. You can…
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