In this role, you have the opportunity to
This position is responsible for performing electrical testing and evaluation on a variety of Medical products to the provisions of U.S., Canadian and other International product safety standards (e.g. IEC/ANSI AAMI / CSA 60601-1 and its Collateral and Particular standards) and; writing reports; and communicating with regulatory agencies.
You are responsible for
- Perform tests to align 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 efficient test strategies are implemented in a timely manner and detailed in accordance with applicable global standards.
- Assist product development and manufacturing maintain proper testing & product configuration data to demonstrate continued compliance.
To succeed in this role, you should have the following skills and experience
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- BS. Electrical Engineering (preferred), or Mechanical Engineering.
- Demonstrated, hands on, 6+ years of experience in testing and obtaining certification to safety standards for medical devices.
- Experience interacting with regulatory agencies and participating in audits.
- Possess excellent verbal and written communication skills as well as interpersonal skills vital to work across multiple engineering disciplines, and project management.
- Ability to work independently & validated proficiency in project management, problem solving, and MS Office tools (Word, PowerPoint, etc)
- Experience with wireless compliance is a preferred.