Senior Hardware Engineer
About this role
Must-Have Skills
- 10+ years of experience in Medical Device Hardware Development
- Analog, Digital & Mixed-Signal Design
- MCU, FPGA, Sensor Interface Design
- Power Electronics, Battery-Powered Devices, DC-DC Converters
- High-Speed PCB Design (Ethernet, USB, SPI, I2C, CAN)
- PCB Design, DFM, DFT, SI/PI Analysis
- CAPA, NCR, Change Control & Obsolescence Management
- Component Qualification & Alternate Part Evaluation
- Hardware Verification & Validation (V&V)
- Risk Management (dFMEA, pFMEA, sFMEA)
- Requirement Traceability (RTM)
- IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485
- FDA Medical Device Regulations
- Manufacturing Transfer & Sustaining Engineering
- Windchill / Agile PLM
Key Responsibilities
- Lead hardware design, development, and sustaining engineering activities for regulated medical devices.
- Drive CAPA, change management, obsolescence mitigation, and product improvement initiatives.
- Perform schematic reviews, component selection, PCB design reviews, and hardware validation.
- Execute risk assessments, V&V, compliance testing, and regulatory support activities.
- Support manufacturing transfers, supplier changes, and cost optimization programs.
- Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.
Frequently Asked Questions
Is the salary disclosed for the Senior Hardware Engineer position at Sapsol Technologies Inc?
The salary for this Senior Hardware Engineer role at Sapsol Technologies Inc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Hardware Engineer position at Sapsol Technologies Inc located?
This Senior Hardware Engineer role at Sapsol Technologies Inc is based in Tarrytown, New York, United States. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
How do I apply for the Senior Hardware Engineer position at Sapsol Technologies Inc?
Click the "Apply Now" button on this page. You will be redirected to Sapsol Technologies Inc's official application portal hosted on workable where you can submit your application directly.
When was the Senior Hardware Engineer job at Sapsol Technologies Inc posted?
This Senior Hardware Engineer position at Sapsol Technologies Inc was posted on Sep 9, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Hardware Engineer
Sapsol Technologies Inc
You'll be redirected to Sapsol Technologies Inc's official application page on workable.