Principal Systems Engineer (Medical Devices)

The Principal Systems Engineer will serve as a senior technical leader supporting all phases of medical device platform development, from concept through commercialization and post-market support. This role requires hands-on ownership of system-level architecture and design , extending beyond PCB design, with direct contribution to electromechanical, electrical, mechanical, and software systems . The engineer will collaborate closely with marketing, medical affairs, and clinicians to translate user needs into robust, compliant designs for Class II medical devices, including consoles and single-use disposables used in ablation procedures. Responsibilities Lead system architecture design for complex electromechanical medical devices Architect, design, prototype, test, and release to production console systems and single-use disposables Perform critical component selection , subsystem design, and integration Develop and manage system diagrams, requirements, specifications, test plans, and V&V documentation Ensure compliance with IEC 60601 and applicable regulatory standards Support formative and preclinical studies by working directly with physicians and users Collaborate cross-functionally to optimize designs based on test data and user feedback Act as a hands-on technical leader, independently executing design, build, and test activities Partner with external vendors to accelerate development and validation Qualifications Bachelor's degree in Electrical Engineering, Software Engineering, or related field 12+ years of experience in electronics and system design for medical product development Proven leadership in product/system-level architecture beyond PCB design Experience with ablation devices and MRI-compatible equipment strongly preferred Expertise in electromechanical product development , from prototype to production Proficiency with Altium Designer , SolidWorks , and JAMA (requirements management) Strong background in schematic capture, PCB layout, embedded systems, sensors, RF, motors, pumps, and valves Ability to work independently without reliance on test engineers or technicians