Virtue America is looking for a mid-senior engineer to design, integrate, and support complex medical devices. The role involves working with electronics, mechanical, and embedded systems while ensuring compliance with medical device regulations.
Responsibilities:
- Design, integrate, and support complex medical devices involving electronics, mechanical, and embedded systems
- Hardware & systems design (PCBA, sensors, integration)
- Medical device compliance (FDA 21 CFR 820, ISO 13485)
- Design controls, V&V, DHF documentation
- Root cause analysis & product improvement
- Cross-functional collaboration
Requirements:
- 5–8+ years of experience in systems engineering
- Experience in designing, integrating, and supporting complex medical devices
- Proficiency in hardware & systems design (PCBA, sensors, integration)
- Knowledge of medical device compliance (FDA 21 CFR 820, ISO 13485)
- Experience with design controls, V&V, DHF documentation
- Ability to perform root cause analysis & product improvement
- Experience in cross-functional collaboration