Principal Electrical Engineer, Research and Development

Description

JOB SUMMARY: 

The Principal Electrical Engineer will serve as the technical lead and subject matter expert for the design and development of electrical systems within medical devices. This role will focus on innovation, compliance, and robust product development from concept through commercialization. 

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: 

• Lead the electrical design and development of Class II/III medical devices from concept through production.
• Ensure compliance with IEC 60601, including risk management, EMC/safety testing, and documentation requirements.
• Architect and design analog and digital circuits, including power management, signal processing, and communication interfaces.
• Oversee and perform schematic capture, PCB layout review, and component selection.
• Collaborate cross-functionally with mechanical, manufacturing, regulatory, and quality engineering teams.
• Serve as the electrical technical lead during design reviews and verification/validation phases.
• Manage and contribute to electrical V&V protocols, FMEA, and risk assessments.
• Interface with external testing labs to execute and resolve issues in pre-compliance and formal IEC 60601 testing.
• Guide junior engineers and contribute to mentoring and technical development of the team.
• Support sustaining engineering efforts, root cause investigations, and implementation of design improvements.
• Maintain up-to-date knowledge of medical device regulations, including FDA, ISO, and EU MDR.

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

• Expert knowledge of IEC 60601 standards, including general, collateral, and requirements for medical electrical equipment including battery powered equipment.
• Strong understanding of electrical safety, EMC/EMI mitigation, risk management, and design for reliability in regulated medical environments.
• Proficiency in analog and digital circuit design, including power regulation, signal conditioning, and microcontroller integration.
• Skilled in electrical CAD tools (such as Altium) for schematic capture and PCB design.
• Familiar with circuit simulation tools and hardware debugging using oscilloscopes, logic analyzers, and other lab equipment.
• Ability to design and build test fixtures and program with LabView or equivalent (as required)
• Strong analytical and problem-solving skills, with a structured approach to troubleshooting and root cause analysis.
• Demonstrated ability to interpret and apply regulatory standards (FDA, ISO 13485, IEC 60601, ISO 14971) to product development.
• Ability to manage multiple priorities and make informed decisions under ambiguity.
• Effective communication skills for writing technical reports, presenting to leadership, and interfacing with regulatory bodies or test labs.
• Strong organizational and time-management abilities with a high level of attention to detail.
• Collaborative mindset with a track record of mentoring engineers and influencing cross-functional teams.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Electrical Engineering or equivalent, MS preferred.
• 10+ years of progressive R&D experience, preferably in medical devices.
• Proven track record of leading complex, cross-functional development programs from concept through commercialization.
• Extensive experience with design controls and risk management
• Excellent documentation and communication skills, with the ability to translate technical information clearly.

PHYSICAL REQUIREMENTS:

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 25-50 pounds at times.