Qualifications

• 10+ years of experience in Medical Device Hardware Development
• Expertise in Analog, Digital & Mixed-Signal Design
• Strong background in MCU, FPGA, and Sensor Interface Design
• Proficient in Power Electronics, particularly battery-powered devices
• Experience with High-Speed PCB Design including protocols like Ethernet, USB, SPI, I2C, and CAN
• Familiarity with PCB Design for manufacturability (DFM), Testability (DFT), and Signal Integrity (SI) analysis
• Knowledge of CAPA, NCR, Change Control, and Obsolescence Management
• Experience with Hardware Verification & Validation (V&V) and Risk Management (dFMEA, pFMEA, sFMEA)
• Skilled in adhering to IEC and ISO standards relevant to medical devices
• Understanding of FDA Medical Device Regulations and Manufacturing Transfer processes

Responsibilities

• Lead hardware design and development for regulated medical devices
• Drive initiatives for CAPA, change management, and product improvement
• Conduct reviews of schematics, component selections, and PCB designs
• Execute risk assessments and validate adherence to compliance standards
• Support the transfer of manufacturing processes and supplier changes
• Collaborate effectively across various departments including Systems, Firmware, and Quality

Benefits

• Healthcare, dental, and vision insurance
• Generous paid time off and holiday schedule
• Retirement savings plan with company match
• Continuous learning and professional development opportunities
• Flexible work arrangements and a supportive work culture