About this opportunity
Accord Technologies Inc lists this Senior Hardware Engineer Medical Devices PCB opportunity in village of tarrytown, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Senior Hardware Engineer Medical Devices
Location: Tarrytown, NY, USA
Positions: 1
Visa: USC/GC/H1B
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
Preferred Skills
IVD / Clinical Diagnostics / Medical Equipment
Cost Reduction, VAVE & Should-Cost Analysis
Safety & EMC Compliance Testing
Supplier Qualification & Product Lifecycle Management
Agile / Scrum Project Execution
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.
#J-18808-Ljbffr
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.