Senior Electrical Engineer
Regenesis
This role will serve as the primary electrical engineering resource while developing a broad understanding of the complete medical device system, including mechanical design, RF communications, firmware, software interfaces, and manufacturing processes. The Senior Electrical Engineer will collaborate closely with cross-functional teams, Contract Manufacturing partners, and Engineering Design Consultants to support design changes, troubleshoot technical issues, and contribute to future product development efforts. The ideal candidate is a strong electrical engineer who enjoys working in multidisciplinary environments and is capable of moving between schematic reviews, hardware debugging, system integration activities, and technical problem-solving across the product lifecycle. Essential Duties and Responsibilities The essential functions include, but are not limited to the following: Electrical Design & Product Support Serve as the primary electrical engineering resource for released and developing products. Design, analyze, test, and troubleshoot analog, digital, mixed-signal, and embedded electronic systems. Review schematics, PCB layouts, component selections, and electrical architectures. Support product reliability, performance improvements, and cost reduction initiatives. Evaluate and implement engineering changes to released products. System Integration & Technical Problem Solving Develop a strong understanding of the complete medical device system, including electrical, mechanical, RF, firmware, software, and manufacturing elements. Support cross-functional troubleshooting and root cause investigations. Participate in system integration activities and subsystem compatibility assessments. Evaluate the impact of proposed design changes across multiple engineering disciplines. Support verification and validation testing activities. Lead electrical engineering aspects of product changes and enhancements. Support component obsolescence mitigation and redesign efforts. Participate in complaint investigations, CAPAs, and field issue resolution. Generate and maintain design documentation in accordance with quality system requirements. New Product Development Contribute to next-generation product development efforts. Participate in concept development, feasibility studies, and technology evaluations. Support requirements development and technical risk assessments. Collaborate with internal and external engineering teams during product development. External Partner Collaboration Work closely with Contract Manufacturing partners and Engineering Design Consultants. Review technical deliverables related to electrical hardware and system integration. Support design transfer and manufacturing readiness activities. Participate in supplier technical reviews and issue resolution efforts. Knowledge & Skills Bachelor's Degree in Electrical Engineering. 5+ years of electrical engineering experience, preferably in medical devices or another regulated industry. Hands-on experience designing, testing, and troubleshooting electronic systems. Experience with: Analog and digital circuit design PCB development and review Embedded systems Hardware verification and validation Ability to understand and work across firmware, RF, mechanical, and software interfaces. Strong troubleshooting and root cause analysis skills. Excellent communication and collaboration skills. Preferred Qualifications Medical device industry experience. Experience with wireless technologies such as BLE, Wi-Fi, NFC, or proprietary RF systems. Familiarity with FDA design controls, ISO 13485, and ISO 14971. Experience supporting products through manufacturing transfer and commercialization. Experience working with Contract Manufacturers and external engineering firms. Familiarity with battery-powered and portable electronic devices. #J-18808-Ljbffr Regenesis
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