Salary
💰 $162,400 - $243,600 per year
About the role
- Lead and contribute to the design, development, and testing of electrical systems and circuits for medical devices, ensuring compliance with applicable regulatory standards (e.g., IEC 60601)
- Lead and contribute to technical project planning, establish timelines, define deliverables, and proactively identify and mitigate potential risks
- Develop detailed specifications, schematics, and PCB layouts, collaborating closely with cross-functional teams to meet design and performance requirements
- Perform system-level integration of hardware, firmware, and software components
- Conduct risk assessments and root cause investigations for electrical issues, implementing robust corrective and preventive actions
- Manage product changes and related change control activities, ensuring design documentation (e.g., BOMs, specifications, drawings) is updated and maintained accurately
- Partner with reliability and manufacturing teams to optimize designs for scalability, cost efficiency, and high performance
- Support verification and validation activities to ensure the safety, compliance, and efficacy of the product
- Design, develop, and qualify functional and safety test systems at both the product and PCB levels
- Investigate and analyze field-returned products, conducting engineering analyses and testing to determine root causes of failures
- Support and potentially own CAPA (Corrective and Preventive Actions) processes and manage issue escalations to resolution
- Provide troubleshooting and problem-solving support to manufacturing teams and key suppliers, aiming to increase yields, maintain process capabilities, and improve cost-efficiency
- Support internal and external regulatory compliance audits, ensuring adherence to quality and safety standards
- Mentor and coach junior engineers, fostering a collaborative, innovative, and high-performing engineering environment
- Stay current with advancements in electrical engineering, emerging technologies, and industry best practices
Requirements
- Bachelor's degree and a minimum of 10 years of relevant experience OR a Master's degree with a minimum of 8 years of relevant experience OR PhD with 6 years of relevant experience
- Extensive experience in medical device or highly regulated industries
- Expertise in designing, testing, and implementing high-voltage systems (~5 kV)
- Fundamental knowledge of RF systems
- Deep understanding of EMC design and test principles per IEC 60601
- Experience in advanced analog, digital or mixed-signal circuit design and test
- Strong experience with system-level integration of hardware and firmware
- Proficiency with analysis, simulation, and CAD tools for PCB design (e.g., Minitab, MATLAB, SPICE, Altium, Cadence)
- Demonstrated skills in writing engineering documents (specifications, test plans, etc.)
- Hands-on experience with prototyping, testing, and debugging PCB assemblies
- Experience in developing hardware test systems for design verification or production testing
- Knowledge of Design for Manufacturing and Test (DFM & DFT) principles
- Experience with Six Sigma, Lean, or other problem-solving methodologies
- Strong experience in leadership and cross-functional team management
- Demonstrated success in relevant patent filings or professional publications
- Experience mentoring junior engineers and driving technical roadmaps
- Strong verbal and written communication skills
- Team-oriented mindset with a collaborative work ethic