B.S. in Electrical Engineering, Systems Engineering, or related field
5+ years of hardware design and development experience
Hands-on experience with circuit design and PCB development
Familiarity with firmware/embedded systems integration is a plus
Proficiency in electrical CAD/EDA tools
Strong technical writing and documentation skills
Experience in a regulated industry, with knowledge of FDA QSR and ISO standards preferred
Responsibilities
Lead and support electrical design activities including circuit design and component selection
Develop and evaluate hardware prototypes; analyze and report on test data
Define electrical design requirements and translate user needs into specifications
Collaborate with firmware and software teams for system integration
Define and maintain system-level architectures across subsystems
Perform system-level failure mode analysis and hazard assessments
Create and execute V&V protocols for design requirements
Benefits
Opportunity to work across multiple concurrent projects
Engage in a versatile role that spans the full product development lifecycle
Collaborate with cross-functional teams and external partners
Contribute to innovative product development in a regulated industry
Support design transfer to manufacturing and improve R&D workflows
Full Job Description
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
