What are the responsibilities and job description for the Senior Hardware Engineer - Medical Devices || Tarrytown NY position at Techridge, Inc.?
Hello
Position : Senior Hardware Engineer Medical Devices
Location: Tarrytown, NY, USA
Employment Type : Contract
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.
Thanks and regards
Sonali Silswal Team Lead- Talent Acquisition
Email:
Contact:
LinkedIn:
Address: 2591 Dallas Pkwy, Ste 300, Frisco, TX 75034
Website:
Salary : $20 - $50