Senior Hardware Engineer Medical Devices - Tarrytown, NY

Senior Hardware Engineer Medical Devices

Location: Tarrytown, NY, USA

Duration : Long term

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.

Accliive, is an Engineering and IT Talent Services company working with Fortune 500 clients and is based out of Boston, MA. Accliive works extensively in all the major industries like Manufacturing, Semiconductor, Aerospace, BFSI, Oil and Gas, Utilities, Healthcare and many more. Acclive is focused on providing customer centric solutions and career centric solutions.