Medical Device Product & Project Engineer – On-site

Dilon Technologies Inc.; Richmond (VA); Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

Dilon Technologies is seeking a Product / Project Engineer to take next‑generation medical devices from concept to production. You will work directly with the VP of Engineering to convert ideas into clear requirements, maintain project schedules, and write design documentation and V&V protocols that satisfy design controls.

This hands-on, cross-functional role spans hardware, software, mechanical, and manufacturing work.

Qualifikationen

• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Systems, or related).
• 2–5 years of engineering experience in a medical device or regulated setting.
• Exposure to design controls (21 CFR 820 / ISO 13485) and ISO 14971 risk management.
• Experience writing test protocols, test reports, or requirements.
• Strong technical writing and organizational skills.

Aufgaben

• Translate user needs and product goals into clear, testable requirements.
• Plan and track development projects: schedules, tasks, risks, and cross‑discipline work.
• Write V&V plans and protocols with traceability to requirements and risk controls.
• Coordinate test execution and document deviations.
• Maintain requirements traceability from user needs through design inputs/outputs and verification evidence.
• Create risk management files per ISO 14971, including FMEAs and hazard analyses.
• Help prepare DHF content and design review packages for compliance.
• Coordinate testing to IEC standards and liaise with external test labs.
• Support ECOs, anomaly investigations, and CAPAs with impact assessments.
• Assist design transfer with manufacturing engineering and pilot builds.
• Communicate project status and technical questions with suppliers and internal teams.

Kenntnisse

Technical writing

Cross-functional teamwork

Requirements analysis

Project tracking

Regulated industry experience

Ausbildung

Bachelor's degree in engineering

Tools

MS Project

Smartsheet

Gantt charts

Arena PLM

Jobbeschreibung

Dilon Technologies is seeking a Product / Project Engineer to take next‑generation medical devices from concept to production. You will work directly with the VP of Engineering to convert ideas into clear requirements, maintain project schedules, and write design documentation and V&V protocols that satisfy design controls.

This hands-on, cross-functional role spans hardware, software, mechanical, and manufacturing work.