Senior Product Safety Engineer, Electrical
Weston, WI - USA
Job Summary
Join Strykers Mako Robotics team as a Senior Product Safety Engineer helping ensure the safety reliability and regulatory compliance of advanced robotic-assisted surgical technologies.
In 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.
- 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.
- Bachelors 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.
- 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 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.
Additional Information
This 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.
- $89300 - $148800 USD Annual
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.
Required Experience:
Senior IC
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more