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Senior Hardware Engineer Medical Devices - Tarrytown, NY

Tarrytown, NY, US • Posted 4 hours ago • Updated 2 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

FMEA
PCB
CAPA

Summary

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10415550
Position Id: 2026-4798
Posted 4 hours ago

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