Senior Electrical Engineer, Combination Product Development

Role: Senior Electrical Engineer in Combination Product Development within R&D, focusing on design and development of electronic systems for advanced drug-device combination products such as on-body injectors and infusion pumps. Main objectives include leading electrical system design efforts, ensuring regulatory compliance, and supporting new device platform innovations. Responsibilities encompass collaboration with external partners on circuit and PCB design, conducting feasibility assessments, system architecture evaluation, and supporting validation activities. The role also involves cross-functional engagement with clinical, regulatory, quality, and engineering teams to ensure development milestones align with regulatory standards. Qualifications: BS in Electrical Engineering or similar with 10+ years (MS with 8+ years), demonstrated expertise in medical device or combination product development, especially in electromechanical healthcare devices. High-value details: experience with drug delivery systems, subcutaneous injection devices, embedded systems, and familiarity with global regulatory standards (e.g., 21 CFR 820.30, ISO 13485). The role requires strong technical leadership, project management, and communication skills. Travel is estimated at 5-10%, and the position involves working with multidisciplinary teams across R&D, regulatory, and external partners.