Compliance Engineer, Product Safety & Compliance

Your role

• Perform tests to comply with current global product safety standards (e.g. IEC 60601-1 and its Collateral and Particular standards)
• Complete preliminary design reviews. Develop and set up test plans. Set up and operate standard test equipment including, but not limited to, Power Meter or power Analyzer, Data logger, spectrum analyzer, oscilloscope, dielectric strength tester, ground continuity tester, digital multi-meter, surge generator, over-voltage tester, environmental condition chamber etc. Core tests include, but are not limited to: Power Input or rating, leakage current, dielectric, temperature, pressure, stability, mechanical hazard, flammability, abnormal operations or single faults, rain, radiation, sound etc.
• Compile test results during construction review and testing. Submit report to regulatory agency for final approval.
• Review emerging regulations and changing standards for potential impacts. Propose compliance plans to meet changing requirements.
• Interface and participate, as needed, in site inspections from certification agencies.
• Act as liaison with external testing & certification suppliers to assure accurate and cost-effective test strategies are implemented in a timely manner and documented in accordance with applicable global standards.
• Assist product development and manufacturing maintain proper testing & product configuration data to demonstrate continued compliance.

You're the right fit if

• You've acquired 1+ years of experience supporting product safety, compliance, and certification activities for medical devices in a regulated environment. Experience with product safety testing and working with certification organizations is highly valued.
• Your skills include interpreting and applying medical device safety standards, including International Electrotechnical Commission (IEC) 60601 and International Organization for Standardization (ISO) 80601 requirements. Bonus skills include experience with electromagnetic compatibility testing, wireless compliance requirements, respiratory medical devices, or Artificial Intelligence tools and technologies.
• You have the ability to work independently & proven proficiency in project management, problem solving, and MS Office tools (Word, PowerPoint, etc)
• You have a Bachelor's degree in Electrical, Mechanical, Biomedical, or another Engineering discipline.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You're an independent and collaborative professional who communicates effectively with a variety of stakeholders and is comfortable influencing decisions related to product safety and compliance. You demonstrate initiative, ownership, and accountability while thriving in a highly technical environment.