We are seeking a highly skilled Senior Electrical Engineer with a diverse scope of experience designing, testing, and sustaining medical devices. The ideal candidate has a strong foundation in electrical engineering principles, motivated self-starter who understands the regulatory and quality requirements of the medical device industry. The incumbent has significant experience resolving component-level sourcing challenges and thrives in a fast-paced, cross-functional environment. This role will support the development, optimization, and maintenance of complex electromechanical medical products.
Key Responsibilities
Sustaining Engineering
Diagnose and resolve electrical issues in existing products, including component obsolescence, field failures, and manufacturing challenges.
Lead root cause analysis and implement corrective and preventive actions (CAPA).
Evaluate failure trends, collect and organize data, provide recommendations to mitigate risks, and implement long-term solutions.
Documentation & Compliance
Generate engineering documentation, including schematics, test plans, risk assessments, and verification reports.
Ensure designs comply with medical device standards (e.g., IEC 60601, ISO 13485, ISO 14971).
Develop project plans, change requests, identify risks and mitigation strategies.
Testing & Validation
Develop and execute test protocols for electrical subsystems and full devices to meet safety and performance requirements.
Support EMC and safety validation activities.
Cross-Functional Collaboration
Partner with R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams throughout the product lifecycle.
Provide technical support to production and supplier partners as needed.
Qualifications
Education & Experience -Required
Bachelor’s degree in electrical or Electronics Engineering,
3–5+ years of experience in electrical design for medical devices or other regulated industries.
Familiar with IPC-A-610 and IPC-J-STD-001
Hands-on experience with:
PCB design and layout tools (e.g., Altium, OrCAD, PADS).
Analog and digital circuit design.
Electrical testing tools (oscilloscopes, logic analyzers, power analyzers).
Laser and optical system troubleshooting
Strong understanding of regulated product development and design controls.
Demonstrated ability to troubleshoot complex electromechanical systems.
Project management experience
Preferred Qualifications:
Master’s degree in Electrical Engineering
5 or more years of experience with:
Embedded systems and microcontroller-based designs.EMC/EMI mitigation.
Firmware integration in a medical device environment.
Knowledge of FDA 21 CFR Part 820, IEC 60601-1, and related standards.
Experience supporting sustaining engineering activities.
PMP certification
The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.