Fractyl Health

Reports to: Associate Director of Engineering 

Position Summary 

The Electrical Engineer II works in a small, cross functional team of capable and experienced engineers who are working to develop a novel therapeutic system that includes both capital equipment and disposable components. Working with our team, this position is ideal for those seeking a unique opportunity to design the next generation of medical device products in a fast paced, dynamic and mission focused company. With serviceability, manufacturability and reliability at the heart of the design, the Electrical Engineer II works closely with Fractyl Stakeholders to develop, test and introduce safe and highly effective products. 

Primary Responsibilities 

With guidance from senior staff members and expert consultants, the Electrical Engineer II will: 

• Perform various tasks in electrical hardware design, development, integration, and testing of capital systems and single use disposable products.
• Design, prototype, and debug electrical hardware. Hands-on work is expected.
• Ensure a robust design using power derating analysis and other analytical tools. 
• Translate stakeholder requirements into system and technical requirements in collaboration with the Systems Engineering team.
• Work closely with Mechanical, Software, and Systems Engineers to enable successful system integration.
• Identify and mitigate risks associated with electrical designs and the overall system. Contribute to Top-Down Risk Assessment and dFMEAs.
• Ensure designs and systems comply with industry standards, namely IEC 60601 Electrical Safety Standards. 
• Design, test and evaluate electronic designs with regards to IEC 60601-1 and IEC 60601-1-2 Electrical Safety Standards. 
• Assist in testing with NRTLs, compile results and produce reports demonstrating compliance to applicable standards. 
• Produce high-quality design documentation.
• Document rationales for design decisions and theory of operation documents.
• Conduct design reviews, effectively communicate and collect feedback on the impact of design changes throughout the stages of product development.
• Perform verification testing.
• Develop and validate test methods and fixtures.
• Define and lead verification plans for the electrical system.
• Write test protocols and reports to document test processes and analyses of results. 
• Support design transfer to manufacture and commercialization phases.
• Develop and train others to manufacturing work instructions and functional test procedures in collaboration with Manufacturing and Quality teams.
• Work with Fractyl’s manufacturing team and contract manufacturers to resolve production issues and investigate nonconforming material.
• Support design improvements for better reliability, manufacturability, serviceability, and reduced cost. 
• Perform sustaining engineering activities related to electronics, for Fractyl’s existing products. 
• Perform all activities in compliance with applicable regulations and Fractyl’s policies guidelines, and Quality System, including but not limited to timely documentation of design and verification activities and maintaining all required training.
• Bring a “can do” spirit to work and deliver on other responsibilities as assigned. 

Education or Certification Requirements 

• Bachelor’s degree in electrical engineering, computer engineering or equivalent. 

Professional Work Experience 

• 3+ years hands-on experience in new product research and development. Medical device experience is desired but not required. 
• Experience with full product lifecycle is desired but not required. 
• Applicable experience in biotech, pharmaceutical and/or medical device industries preferred. 
• Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.). 

Tools and Technology 

• Fractyl Health builds a highly integrated electromechanical therapeutic system, incorporating fluidics, linear motion control, and sensor systems. Our electrical system includes embedded microcontrollers, analog and power electronics, and uses communications protocols including Ethernet, SPI, I2C, and UART 
• We design PCBs in Altium, KiCAD and use C, C++, and Python to develop software and control systems. 

Qualifications and Skills 

• Proficiency in PCBA design from schematic capture through layout and manufacturing, including analog, digital, power, and embedded microcontroller circuitry. Experience with SPICE or other simulation tools is a plus. 
• Experience with complex electromechanical systems, including design, integration, and troubleshooting. Prior experience with motion control systems is a plus.
• Experience with electromagnetic compatibility testing, including emissions and immunity testing. Comfort with EMC troubleshooting and design best practices. 
• Proficiency with test and measurement equipment such as power supplies, oscilloscopes, multimeters, and spectrum/signal/logic analyzers. 
• Risk management and/or dFMEA experience. 

Other Essentials and Key Success Factors 

• Successful track record of working in high-growth and dynamic organizations 
• Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit 
• Ability to lead fast-paced projects with a keen sense of urgency to get the job done well 
• Evidence of "hands-on" experience and expertise 
• Proven and successful track record as a team-player and collaborator in small working environments 
• Highly organized and detail oriented with a passion to deliver quality results 
• Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation 
• Highest levels of professionalism, confidence, personal values and ethical standards 

Travel 

• Some infrequent domestic travel will be required. 

The description and requirements outlined above are general; additional requirements may apply.