Senior Hardware Engineer

Job Description

Senior Hardware Engineer – Medical Devices

\n

Location: Tarrytown, NY, USA

\n

Must-Have Skills

\n

\n
• 10+ years of experience

\n

• Analog, Digital & Mixed-Signal Design

\n

• MCU, FPGA, Sensor Interface Design

\n

• Power Electronics, Battery-Powered Devices, DC-DC Converters

\n

• High-Speed PCB Design (Ethernet, USB, SPI, I2C, CAN)

\n

• PCB Design, DFM, DFT, SI/PI Analysis

\n

• CAPA, NCR, Change Control & Obsolescence Management

\n

• Component Qualification & Alternate Part Evaluation

\n

• Hardware Verification & Validation (V&V)

\n

• Risk Management (dFMEA, pFMEA, sFMEA)

\n

• Requirement Traceability (RTM)

\n

• Manufacturing Transfer & Sustaining Engineering

\n

• Windchill / Agile PLM

\n

\n

\n

Key Responsibilities

\n

\n
• Lead hardware design, development, and sustaining engineering activities for regulated medical devices.

\n

• Drive CAPA, change management, obsolescence mitigation, and product improvement initiatives.

\n

• Perform schematic reviews, component selection, PCB design reviews, and hardware validation.

\n

• Execute risk assessments, V&V, compliance testing, and regulatory support activities.

\n

• Support manufacturing transfers, supplier changes, and cost optimization programs.

\n

• Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.

\n

\n