Senior Hardware Engineer Medical Devices
Location: Tarrytown, NY (Onsite)
Job Type: Contract / Direct Hire
Experience: 10+ Years
Industry: Medical Devices / Healthcare
Job Summary
We are seeking a highly experienced Senior Hardware Engineer with strong expertise in medical device hardware development, analog/digital electronics, embedded hardware, PCB design, verification and validation, and sustaining engineering.
The ideal candidate will have experience developing and supporting regulated medical devices throughout the product lifecycle, from hardware architecture and design through V&V, regulatory compliance, manufacturing transfer, and sustaining activities.
Key Responsibilities
- Lead hardware design, development, and sustaining engineering activities for regulated medical devices.
- Develop and review analog, digital, and mixed-signal electronic designs.
- Design and support hardware involving MCUs, FPGAs, sensor interfaces, and embedded electronics.
- Work on power electronics, battery-powered systems, DC-DC converters, and power management circuits.
- Perform schematic reviews, component selection, PCB design reviews, and hardware design assessments.
- Support high-speed interfaces including Ethernet, USB, SPI, I2C, and CAN.
- Apply DFM, DFT, Signal Integrity (SI), and Power Integrity (PI) principles to hardware development.
- Execute hardware verification and validation activities and support compliance testing.
- Develop and maintain hardware requirements and Requirement Traceability Matrices (RTM).
- Perform risk assessments and support dFMEA, pFMEA, sFMEA, and other product risk-management activities.
- Support compliance with IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485, and applicable FDA requirements.
- Drive CAPA, NCR resolution, engineering changes, component obsolescence, and product improvement initiatives.
- Evaluate alternate components and lead component qualification activities.
- Support manufacturing/design transfers, supplier changes, NPI, and production engineering activities.
- Participate in cost-reduction, VAVE, and product lifecycle initiatives.
- Collaborate closely with Systems, Firmware, Mechanical, Quality, Regulatory, Manufacturing, and Supplier teams.
Required Qualifications
- Bachelor's or Master's degree in Electrical Engineering, Electronics Engineering, or a related technical discipline.
- 10+ years of hardware/electronics engineering experience, preferably with significant medical-device development experience.
- Strong hands-on experience with analog, digital, and mixed-signal circuit design.
- Experience with MCU, FPGA, sensor interfaces, and embedded hardware.
- Strong knowledge of PCB design, high-speed interfaces, DFM/DFT, and SI/PI considerations.
- Experience with hardware verification and validation.
- Strong understanding of medical-device risk management and regulatory requirements.
- Hands-on experience with IEC 60601 and/or other applicable medical-device standards.
- Experience with CAPA, NCR, change control, component qualification, and obsolescence management.
- Experience supporting manufacturing transfer and sustaining engineering activities.
Preferred Qualifications
- Experience in IVD, clinical diagnostics, laboratory systems, or medical equipment.
- Experience with VAVE, cost reduction, and should-cost analysis.
- Experience with safety, EMC, and regulatory compliance testing.
- Experience with supplier qualification and product lifecycle management.
- Familiarity with Windchill, Agile PLM, or similar PLM/change-management systems.
- Experience working in Agile/Scrum product-development environments.
Ideal Candidate
The ideal candidate is a senior-level medical device hardware engineer who can work across hardware design, embedded electronics, compliance, V&V, risk management, manufacturing transfer, and sustaining engineering in a highly regulated environment.
Never miss an opportunity! Create an alert based on the job you applied for.