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
