Principal Systems Engineer

4 weeks ago

Saint Paul MN, United States CONFLUX SYSTEMS Full time

No C2C / Only W2 / No Sponsorship 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.
Lead system architecture design for complex electromechanical medical devices
Architect, design, prototype, test, and release to production console systems and single-use disposables
Ensure compliance with IEC 60601 and applicable regulatory standards
Collaborate cross-functionally to optimize designs based on test data and user feedback
Bachelor’s degree in Electrical Engineering, Software Engineering, or related field
~12+ years of experience in electronics and system design for medical product development
~ 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

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