Project Manager/Product Engineer

Dilon Technologies; Newport News (VA); On-site; USD 70,000 - 100,000; Full time

Job summary

Dilon Technologies is seeking a Product / Project Engineer to move next‑gen medical devices from concept to production. You’ll report to the VP of Engineering, turning ideas into clear requirements, maintaining design controls, and writing V&V plans and protocols.

This hands‑on role spans hardware, software, and manufacturing with broad exposure to the product lifecycle. The position emphasizes collaboration across engineering, operations, and suppliers, with growth toward systems engineering or

Qualifications

• Bachelor’s degree in engineering (any discipline).
• 2–5 years of engineering experience in medical devices or regulated environments.
• Exposure to design controls (21 CFR 820 / ISO 13485) and risk management (ISO 14971).
• Experience writing test protocols, test reports, or requirements.
• Strong technical writing and documentation skills.
• Strong organizational skills; ability to manage multiple priorities.

Responsibilities

• Translate user needs into clear, testable product and subsystem requirements.
• Plan and track development projects with schedules, tasks, and risks.
• Write V&V plans and protocols with traceability to requirements and risk controls.
• Coordinate test execution and write test reports; document deviations.
• Maintain requirements traceability from user needs through design inputs/outputs and risk controls.
• Create risk management files per ISO 14971, including hazard analyses and FMEAs.
• Build and maintain DHF content; prepare design review packages and compliant documentation.
• Coordinate testing to IEC 60601-1 and IEC 60601-1-2 with labs.
• Support ECOs, anomaly investigations, and CAPAs; assist design transfer with manufacturing.

Skills

Technical writing

Project coordination

Systems thinking

Cross-functional

Regulatory knowledge

Education

Bachelor's degree in engineering

Tools

MS Project

Smartsheet

Arena PLM

Gantt charts

Job description

Product / Project Engineer

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 MarginProbe, Navigator, and TrueView, 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 Role

Dilon 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.

What We’re Looking For

• 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 produce clear, organized documentation that others can follow.
• Strong organizational skills. You can track multiple priorities and keep projects moving without constant direction.
• Enough technical breadth to understand electrical, mechanical, and software work and how they fit together.
• Comfort asking questions, pushing for clarity, and following through until work is done.
• Collaborative and professional. You build good working relationships across engineering, operations, and suppliers.

Nice to Have

• Hands‑on experience with V&V testing or IEC 60601‑1 / -1‑2 testing.
• Experience with project management tools and methods (e.g., MS Project, Smartsheet, Gantt charts).
• Background in imaging, nuclear medicine, or surgical/radiation detection devices.
• Experience with Arena PLM or a similar PLM/eQMS system.
• Exposure to FDA 510(k) submissions or EU MDR technical documentation.

Why Join Us

• Broad exposure. You’ll see every part of product development, from requirements through production.
• A clear growth path toward systems engineering or project leadership.

• Dilon Technologies is an equal opportunity employer. We do not discriminate based on race, color, religion, sex, national origin, age, disability, or any other protected characteristic under applicable law.