Senior Product Safety Engineer, Electrical
About The Position
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 technologies. This hands-on engineering role partners closely with electrical, systems, and cross-functional engineering teams to identify and mitigate product safety risks throughout development. The role supports electrical safety and electromagnetic compatibility (EMC) testing, troubleshoots technical challenges, and helps ensure products meet applicable industry standards. It is suited to 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. The position is based in Weston, Florida, and may require occasional travel to other Stryker locations and external testing laboratories to support product safety and compliance activities. Travel is 10%.
Requirements
- Bachelor's degree in Electrical Engineering or a related engineering discipline.
- At least 2 years of relevant engineering experience in electrical engineering, product development, hardware testing, product safety, or a closely related technical field.
Nice To Haves
- Understanding of electrical engineering fundamentals, including electrical circuits, system behavior, and troubleshooting methodologies.
- Working knowledge of 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 electrical, mechanical, software, and systems engineering teams to resolve product safety or compliance challenges.
- Familiarity with engineering tools such as Altium, Jama, Jira, or equivalent design and documentation systems.
Responsibilities
- Identify, evaluate, and document electrical and system-level safety hazards.
- Develop and maintain risk management documentation, including hazard analyses, FMEAs, and safety assessments, and recommend practical risk mitigation strategies.
- Apply electrical safety and EMC principles to evaluate product designs, identify potential compliance concerns, and support troubleshooting and design improvements.
- Interpret and apply relevant medical device safety standards, particularly IEC 60601, its relationship to ISO 14971, and applicable regulatory requirements.
- 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 testing issues.
- Work with electrical, systems, mechanical, and software engineers to integrate safety requirements into product development, identify potential issues early, and support iterative design testing.
- Investigate safety-related test failures and nonconformances, perform root cause analysis, and collaborate with engineering teams to develop and verify corrective actions.
- Maintain accurate safety documentation, test evidence, and requirements traceability.
- Provide technical input for design reviews, verification activities, and regulatory submissions.
- Contribute to improvements in product safety processes, testing practices, and engineering documentation, and share technical knowledge and best practices across project teams.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
