Hardware Engineer (Medical Devices) - SF Bay Area

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This small medical device company seeking a Hardware Engineer to be responsible for the development and maintenance of the electrical hardware design that drives their therapeutic devices. The Hardware Engineer will be involved in hardware development through all phases of the product development process, including schematic drafting, HW risk analysis, PCB/PCBA layout, architecture and design input, prototyping and debugging, SW integration, verification.

Responsibilities

• Contribute to the full product development lifecycle. 
• Participate in electrical hardware detailed design from prototype to commercial transfer. 
• Delivery of medical-grade hardware designs that meet defined requirements. 
• Collaborate with team members across engineering disciplines including mechanical  & software engineering, marketing, quality, regulatory affairs, and  manufacturing. 
• Design  and develop simple, intuitive solutions, which address complex design inputs. 
• Develop bench test methods and perform/delegate hands-on testing of products as appropriate. 

Qualifications

• B.S. in Electrical Engineering or equivalent experience in a related industry. 
• Previous design experience and commercial deployment of IoT appliances and cloud computing. 
• Experience developing schematics and layouts in Altium. 
• Experience with lithium ion battery systems including charging, cell protection, and energy monitoring hardware. 
• Previous design experience and commercial deployment of IoT appliances and cloud computing. 
• Experience developing schematics and layouts in Altium. 
• Experience with lithium ion battery systems including charging, cell protection, and energy monitoring hardware. 

Preferred Medical Device Experience

• 2+ years of embedded Hardware development in a FDA regulated field. 
• Familiarity with Electrical/Software standards IEC 60601/62366.
• Have solid grasp of design verification and software control per 21 CFR 820.30.
• Competency in human factors engineering and usability engineering for medical devices (IEC60606-1-6, IEC 62366). 

Visa Requirements: Must be a US Citizen or US Green Card Holder

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