Senior Product Safety Engineer, Electrical

Work Flexibility:
Onsite It's Time to Join Stryker!

Join Stryker's Mako Robotics team as a Senior Product Safety Engineer, helping ensure the safety, reliability, and regulatory compliance of advanced robotic-assisted surgical  this hands-on engineering role, you will partner closely with electrical, systems, and cross-functional engineering teams to identify and mitigate product safety risks throughout development. You will support electrical safety and electromagnetic compatibility (EMC) testing, troubleshoot technical challenges, and help ensure products meet applicable industry standards.

This opportunity is ideal for an engineer with a strong electrical foundation who enjoys practical problem-solving, laboratory testing, and collaborating with design teams to develop safe, high-quality medical devices.

What You Will Do Product Safety &

Risk Management:

Identify, evaluate, and document electrical and system-level safety hazards. Develop and maintain risk management documentation, including hazard analyses, FMEAs, and safety assessments, while recommending practical risk mitigation strategies.

Electrical Safety & EMC:
Apply electrical safety and electromagnetic compatibility principles to evaluate product designs, identify potential compliance concerns, and support troubleshooting and design improvements.

Standards & Compliance:
Interpret and apply relevant medical device safety standards, with particular emphasis on IEC 60601 and its relationship to ISO 14971 and applicable regulatory requirements.

Testing & Laboratory Coordination:
Plan, coordinate, and support electrical safety and EMC testing with internal teams and external laboratories, including UL, CSA, TÜV, and other recognized testing organizations. Prepare test documentation, coordinate samples, evaluate results, and help resolve identified issues.

Design

Collaboration:

Work closely with electrical, systems, mechanical, and software engineers to integrate safety requirements into product development, identify potential issues early, and support iterative design testing.

Technical Troubleshooting:
Investigate safety-related test failures and nonconformances, perform root cause analysis, and collaborate with engineering teams to develop and verify effective corrective actions.

Documentation & Regulatory Support:
Maintain accurate safety documentation, test evidence, and requirements traceability. Provide technical input supporting design reviews, verification activities, and regulatory submissions.

Continuous Improvement:
Contribute to improvements in product safety processes, testing practices, and engineering documentation while sharing technical knowledge and best practices across project teams.

What You Need Bachelor's degree in Electrical Engineering or a related engineering discipline is required.

Minimum of 2 years of relevant engineering experience in electrical engineering, product development, hardware testing, product safety, or a closely related technical field is required.

Preferred Qualifications (You do not need all of these)
Demonstrated understanding of electrical engineering fundamentals, including electrical circuits, system behavior, and troubleshooting methodologies.

Working knowledge of electromagnetic compatibility (EMC/EMI) principles and their application to electrical systems, testing, or design troubleshooting.

Ability to interpret technical standards, analyze test results, investigate technical issues, and recommend practical engineering solutions.

Strong analytical, problem-solving, documentation, and communication skills, with the ability to collaborate effectively across engineering disciplines.

Experience supporting medical device development or engineering in another regulated industry.

Familiarity with IEC 60601, ISO 14971, FDA requirements, and medical device risk management practices, including hazard analysis, FMEA, or fault tree analysis.

Hands-on experience with EMC or electrical safety testing, including test setup, troubleshooting, data interpretation, or coordination with external testing laboratories.

Understanding of EMC design considerations, including conducted and radiated interference, shielding, grounding, coupling mechanisms, PCB and cable parasitics, and current return paths.

Familiarity with medical electrical safety concepts such as essential performance, insulation diagrams, means of operator protection (MOOP), means of patient protection (MOPP), and programmable electrical medical systems.

Experience collaborating with…