Electrical & Systems Engineer

About the role

• The Electrical & Systems Engineer is a versatile technical contributor who operates across the full product development lifecycle, from early-stage concept through design transfer and sustaining. Bridging electrical engineering depth with systems-level thinking, this role supports multiple concurrent programs and is well-suited to an engineer who thrives in ambiguity, moves comfortably between projects, and can engage across mechanical, electrical, firmware, and software domains as program needs demand.
• This position reports to the Director of R&D and Engineering.

What you'll do

• Electrical Design & Development
• • Lead and support electrical design activities including circuit design, board layout review, component selection, signal integrity, and power management
  • Develop and evaluate hardware prototypes; collect, analyze, and report on test data
  • Define electrical design requirements and translate clinical user needs into verified hardware specifications
  • Collaborate with firmware and software teams to ensure cohesive system integration
• Systems Engineering

• • Define and maintain system-level architectures across electromechanical, electrical, and software subsystems
  • Translate user needs into integrated system requirements and manage requirements traceability across the product development lifecycle
  • Perform system-level failure mode analysis and hazard assessments per ISO 14971
  • Contribute across multiple concurrent projects in varying capacities, leading technical workstreams on some and supporting others, based on program priority and skillset fit
• Verification, Validation & Regulatory

• • Create and execute V&V protocols for electrical and system-level design requirements; author test reports and design history records
  • Support usability engineering and human factors testing per IEC 62366
  • Ensure electrical designs meet applicable safety and EMC standards including IEC 60601
  • Assist in preparation of regulatory submissions for US (FDA/21 CFR 820), Canada, Europe, and other international markets
  • Maintain compliance with ISO 13485 and applicable international standards
• Design Transfer & Operations

• • Support design transfer to manufacturing, including electrical process development, validation protocols, and cross-functional handoffs
  • Coordinate with external partners including contract manufacturers, component suppliers, and test labs to execute project deliverables
  • Review and approve Engineering Change Orders as needed
• Team & Culture

• • Communicate effectively across cross-functional teams including QA, RA, Operations, and external stakeholders
  • Identify opportunities to improve R&D tools, workflows, and external resource utilization

Qualifications

• B.S. in Electrical Engineering, Systems Engineering, or closely related field
• 5+ years of hardware design and development experience spanning electrical and systems engineering domains
• Hands-on experience with circuit design, PCB development, prototyping, testing, and V&V
• Familiarity with firmware/embedded systems integration a plus
• Proficiency in electrical CAD/EDA tools and standard office software
• Strong technical writing and documentation skills
• Experience in a regulated industry; familiarity with FDA QSR, ISO 13485, IEC 60601, and IEC 62366 preferred