Verum Technical Staffinghttp://cdn.haleymarketing.com/templates/62326/logos/200x200.pnghttp://www.verumtechnical.comhttp://www.verumtechnical.comUSD8596HOURtrue
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
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