Systems Engineer

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