# Senior Hardware Engineer

**Company:** [Sapsol Technologies Inc](https://jobs.workable.com/companies/d2sRa2JYB9JPF5bL4MU2Yu.md)
**Location:** Tarrytown, United States
**Workplace:** on site

[Apply for this job](https://jobs.workable.com/view/fda20981-a299-4dcf-b272-4848feeb5e87)

## Description

**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.