Senior Electrical Engineer

Senior Electrical Engineer

In the position of Senior Electrical Engineer, you will take on a pivotal technical role, driving the design and development of Gentherm's portfolio of patient temperature management devices. This pertains to both our established products and innovative new offerings. Your extensive experience will be leveraged to serve as a vital Subject Matter Expert (SME), providing crucial guidance and proficiency in the field of electrical engineering. This will encompass overseeing design processes, development phases, comprehensive analysis, meticulous testing, and adept troubleshooting, all within the intricate domain of medical devices.

As an influential and pivotal member of the Engineering team, we are seeking a Senior Electrical Engineer who is primed to make a lasting imprint not only on the team's collective dynamics but also on the technological strides we are poised to undertake. This individual will be motivated to venture into unexplored territories within patient temperature management, thereby actively contributing to the shaping of our future business landscape. This role invites you to stretch the boundaries of conventional thought, thereby shaping novel possibilities in patient temperature management and, by extension, playing a definitive role in sculpting our company's trajectory.

• Cultivate Innovation: Contribute to a culture of innovation, creativity and problem solving. You will be actively involved in design concept generation.
• Drive Product Development Opportunities: Assist in driving a continuous flow of exciting new product development projects, exploring opportunities in adjacent and emerging markets.
• Electrical Design and Development: Lead and contribute to the electrical design and development of new medical devices, subsystems, and components. Collaborate with cross-functional teams to ensure seamless integration of electrical components into the overall product architecture.
• Product Testing and Verification: Develop and oversee comprehensive testing and verification procedures for electrical systems and components. Conduct thorough testing to validate the functionality, performance, and safety of electrical designs, ensuring compliance with both internal requirements and external electrical standards (i.e., IEC 60601-1).
• Hardware and Firmware Development: Drive the design and implementation of electrical hardware and firmware solutions. Utilize your in-depth knowledge of microcontrollers, sensors, analog and digital circuits, and power electronics to create robust and efficient designs.
• Risk Analysis and Mitigation: Conduct risk assessments related to electrical system designs. Develop and implement strategies to mitigate identified risks, ensuring that potential hazards are addressed and minimized in the design process.
• Regulatory Compliance: Stay abreast of relevant industry regulations and standards, including FDA guidelines and international electrical safety standards (IEC-60601-1). Ensure that all electrical designs and products comply with these regulations, facilitating smooth regulatory submissions and approvals.
• Technical Leadership: Provide technical leadership and mentorship to junior electrical engineers and cross-functional team members. Share best practices, promote a culture of innovation, and foster continuous improvement in electrical engineering processes.
• Product Lifecycle Support: Support the entire product lifecycle, from concept to commercialization and post-market maintenance. Collaborate with Manufacturing and Quality teams to resolve electrical-related issues and support production processes.
• Documentation and Reporting: Create and maintain accurate and detailed documentation, including design specifications, test protocols, and technical reports.

• Bachelor's Degree in Electrical Engineering.
• 10+ years of experience in a similar role.
• Proficient in interpreting, analyzing, troubleshooting, and testing electrical designs.
• Previous work experience in the Medical Device Industry, demonstrating familiarity with industry-specific challenges and regulations.
• Advanced knowledge of electrical components, including microcontrollers, power supplies, motor control designs, and common manufacturing methods with expertise in identifying failure modes.
• Familiarity with PCB Schematic & Layout process and tools (e.g., Altium Designer or similar schematic and board layout software).
• Hands-on experience with electronic hardware lab tools for design development (e.g., Oscilloscope, Electronic Loads, Function Generator, Spectrum Analyzer, Environmental Chambers).
• Familiarity with design control processes adhering to ISO 13485 or FDA 21 CFR 820 Design Control Guidance for Medical Device Manufacturers.
• Strong communication skills, enabling effective collaboration and project execution.
• Understanding of relevant risk and electrical safety standards, such as ISO 14971, IEC-60601-1, and IEC 60601-1-2.

• Proximity to the Cincinnati facility, allowing for on-site collaboration.
• Prior experience in mentoring junior-level engineers or leading teams, showcasing strong leadership abilities.
• Proficient knowledge of various communication protocols, including SPI, I2C, CAN, USB, RS-232, RS-485, and Ethernet, as well as proficiency in wireless technologies like Wi-Fi and Bluetooth.
• Basic understanding of the software life cycle for medical devices in accordance with IEC 62304, ensuring compliance with relevant software development processes.