We are seeking a Principal Systems Engineer to provide technical leadership across the full product lifecycle for embedded, electro-mechanical medical devices in a regulated environment. The role involves driving system-level clarity, alignment, and execution across requirements, architecture, risk management, integration, verification/validation, and regulatory documentation.
Requirements
- Bachelor's degree or higher in Engineering from an accredited institution and minimum of seven (7) years of combined industry experience in systems engineering and/or product design
- High School Diploma/GED and eleven (11) years of combined industry experience in systems engineering
- Demonstrated understanding and experience in design, development, and testing of embedded, electro-mechanical medical devices
- Experience working in a regulated design environment, including medical device development within FDA and/or ISO-registered quality systems
- Hands-on systems engineering experience, including working knowledge of C or C++ embedded systems, IoT communications, and cybersecurity risk management
- Experience leading system requirements, architecture, integration, and test activities through formal design reviews to final verification and validation
- Proven experience identifying, quantifying, and mitigating technical risks
- Experience driving continuous improvement of processes, tooling, and technical deliverables
Benefits
- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences and Retirement Benefits