Senior Electrical Design Engineer
$120,000–$150,000 year
On-site · Santa Ana, California, United States
Job Summary
Senior Electrical Design Engineer responsible for design and development of electronic systems for critical care medical devices, including PCB design, system wiring, and electro-mechanical integration. Role requires FDA-compliant design control for Class II and III devices, contributions to project planning, data analysis to support production and service, leading manufacturing initiatives, and creation of design inputs, test protocols, and reports. Must have 5+ years of electronic engineering design experience, CAD proficiency, and experience with ISO/IEC/FDA 510K regulatory requirements and verification/validation, plus FMEA for critical care devices. Strong communication, independent and collaborative work abilities, and willingness to work in a office/lab/manufacturing environment. Compensation range is $120,000 to $150,000 annually.
Required Qualifications
- Minimum of 5 years of electronic engineering design and development experience
- Minimum of 5 years of design experiencing using electronic CAD software packages
- Experience with ISO, IEC, and FDA regulatory requirements for 510K submissions related to high reliability critical care medical devices
- Experience with the development and performance of verification and validation testing required for high reliability critical care devices
- Experience in FMEA design requirements for critical care devices
- Strong knowledge of FDA electronic design documentation and test requirements for 510k submissions
- Ability to perform root cause analysis and provide recommendations for non-conforming products
- Excellent listening, proficient in both verbal and written communication, and technical writing skills
- Able to work effectively both independently and in a collaborative team environment
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