Electrical Engineer

Electrical Engineer

Our client in medical devices is currently hiring a Lead Electrical Engineer to lead electrical designs through verification, validation, and regulatory submission. This role is for an Electrical Engineer who designs the electronics inside handheld orthopedic surgical tools (such as powered drills, saws, and cutting instruments). They will own the electrical design, embedded programming, battery systems, and safety testing needed to bring a medical device from concept through FDA approval.

The ideal candidate has experience with medical device product development, including PCB/circuit design, embedded firmware, battery management systems, EMC/EMI testing, and IEC 60601 electrical safety standards. They should understand FDA design controls, ISO 13485 documentation, risk management, and how to design electronics that can withstand sterilization cycles.

The best fit is someone from a medical device OEM (especially orthopedic/surgical tools) who has taken electrical designs through verification, validation, and regulatory submission. Experience in one or more of the following industries ideal:
Medical Devices, Portable medical devices, Cordless power tools, Outdoor power equipment, Portable consumer electronics, Industrial handheld equipment, Mobile robotics or drones.

Position is a permanent role, Contract to Hire is also acceptable for candidate that wants to try things out.

Primary Responsibilities:

Experienced Medical Device Product Development Electrical Engineer to join our team in developing Large Bone Surgical Power Tools Ensure all device circuitry meets design specifications and safety requirements, and program the electronic control systems. This position requires hands-on technical work combined with rigorous attention to regulatory compliance throughout the development process.

Essential

Qualifications:

The ideal candidate brings deep familiarity with medical device standards, particularly IEC 60601-1 and 60601-2 for electrical safety of medical equipment, as well as ISO 13485 quality management requirements. Experience with FDA design controls and documentation practices is essential, as is knowledge of biocompatibility standards as they relate to electrical components. Experience with sterilization-compatible electronics and understanding how autoclaving or other sterilization methods affect battery and circuit design is highly valuable.

Familiarity with IEC 62304 is beneficial.

Technical

Skills:

Strong circuit design and analysis capabilities, embedded systems programming experience, battery management system (BMS) design and integration, EMC/EMI compliance knowledge, and proficiency with relevant simulation and design tools are required. Experience with power electronics in handheld surgical instruments is a significant plus.

What Sets Great Candidates Apart:
We're looking for engineers who understand that medical device development requires a different mindset than consumer electronics. The ability to balance innovation with rigorous risk management, maintain meticulous documentation, and think through failure modes and patient safety implications is crucial. Experience navigating regulatory submissions and working collaboratively with quality and regulatory affairs teams will make you immediately effective in this role.