R&D Systems Electrical Engineer

The Staff R&D Systems Electrical Engineer, Systems will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. This individual will support product testing, sub-system/component qualification and design, and serve on multiple cross-functional initiatives for projects ranging from concept through commercialization.

Essential Responsibilities

• Design, develop, and troubleshoot electro-mechanical products in full compliance with company Design Control procedures and regulatory requirements (FDA, ISO, MDD/MDR)
• Perform hands-on root cause analysis and troubleshooting of electronic systems
• Support circuit design, breadboarding, testing, and electrical characterization activities
• Prototype and evaluate proof-of-concept designs in simulated environments; iterate based on performance and design feedback
• Utilize Altium designer for circuit analysis and design updates (not a pure PCB layout role)
• Define and manage system-level design inputs; ensure proper subsystem/component development and execution
• Design and qualify fixtures and sub-systems for verification, bench testing, and manufacturing
• Plan and execute design verification testing, including compliance with IEC 60601-1, 60601-1-2, and other applicable medical device standards
• Develop and execute in-vitro, in-vivo, verification, and validation test protocols and reports
• Analyze, evaluate, and procure new materials and components to support development and operational goals
• Document work in lab notebooks and design records in accordance with applicable SOPs and Quality Systems
• Identify and manage relationships with suppliers to ensure timely delivery of quality components and services
• Collaborate cross-functionally with engineering, manufacturing, and quality teams from concept through commercialization and sustaining

Must Have Requirements

• Bachelor s degree in Electrical Engineering (Biomedical Engineering not accepted) with 8+ years of experience
• Strong understanding and hands-on experience with analog and digital circuit design, analysis, and component-level testing
• Proficiency with Altium or similar circuit design CAD tools --MUST
• Expertise in troubleshooting, characterization, and defining system-level design inputs
• Experience designing, assembling, and qualifying test fixtures for design verification, bench testing, and manufacturing support
• Strong knowledge of engineering materials, component selection, and design for reliability and manufacturability
• Working knowledge of IEC 60601-1, IEC 60601-1-2, and other relevant collateral standards
• Comfortable working cross-functionally in a collaborative lab environment

Preferred Requirements

• Experience with JAMA requirements management system preferred
• Experience with JIRA preferred