Job Description
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.
Skills
Agile PLM / Oracle PLM (Product Lifecycle Management)unmatched
Analysis Skillsunmatched
Change Controlunmatched
Change Managementunmatched
Component Selectionunmatched
Computer Engineeringunmatched
Computer Firmwareunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cost Controlunmatched
DFT (Design for Test)unmatched
Design Failure Mode and Effects Analysis (DFMEA)unmatched
Electronicsunmatched
Ethernetunmatched
FDA Requirementsunmatched
FPGAunmatched
Hardware Designunmatched
Hardware Developmentunmatched
I2Cunmatched
ISO (International Organization for Standardization)unmatched
International Electro-Technical Commission (IEC)unmatched
Manufacturingunmatched
Manufacturing Requirementsunmatched
Medical Equipmentunmatched
Microcontrollerunmatched
Mixed Signal IC Designunmatched
Printed Circuit Board Designunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Process Improvementunmatched
Product Programsunmatched
Regulatory Complianceunmatched
Risk Analysisunmatched
Risk Managementunmatched
Schematicsunmatched
System Integration (SI)unmatched
Traceabilityunmatched
USBunmatched
V&V Testingunmatched
Validation Testingunmatched
Windchill PLM Softwareunmatched
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