Product Safety Test Engineer

DEKA Research & Development
Manchester
Workplace: OnsiteFull timeFunction: QA, Test & Release EngineeringExperience: 2+ yearsEducation: bachelorsSkills: ["Analytical skills","Troubleshooting","Problem-solving","Organizational skills","Communication"]

Evaluate electrical safety of medical devices throughout development by applying and interpreting product safety standards such as IEC 60601-1. Conduct investigational and compliance testing in DEKA’s Product Safety Laboratory, including test setup, instrument operation, data analysis, and documentation. Partner with multidisciplinary teams to address compliance risks early via test plans, TRFs, and external lab coordination, while supporting failure investigations and continuous improvements to laboratory capabilities.

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DEKA Research & Development
DEKA Research & Development
2 days ago

Product Safety Test Engineer

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Source: Company careers pageValidated by: Fursa AI
Last checked: 19 hours agoStatus: Live

Job Summary

Evaluate electrical safety of medical devices throughout development by applying and interpreting product safety standards such as IEC 60601-1. Conduct investigational and compliance testing in DEKA’s Product Safety Laboratory, including test setup, instrument operation, data analysis, and documentation. Partner with multidisciplinary teams to address compliance risks early via test plans, TRFs, and external lab coordination, while supporting failure investigations and continuous improvements to laboratory capabilities.
Location: Manchester
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering

Key Responsibilities

  • •Interpret and apply product safety standards (including IEC 60601-1) to support DEKA medical device compliance.
  • •Perform formal compliance testing and investigational testing using internal procedures and applicable standards, including instrument setup, operation, and electrical safety evaluations.
  • •Develop, execute, and document product safety test plans, test cases, and compliance test reports with accurate recording of methods, conditions, results, and conclusions.
  • •Support compliance risk management with cross-functional teams, recommending investigational testing and design improvements to resolve issues early.
  • •Coordinate internal and external accredited laboratory compliance testing when applicable and prepare IEC 60601 Technical Report Forms (TRFs) and documentation for regulatory submissions.

Key Requirements

  • •Bachelor's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related engineering discipline (preferred).
  • •Two years minimum hands-on product safety or electrical safety testing using established test methods, procedures, and applicable industry standards.
  • •Two years minimum experience configuring test setups, operating laboratory instrumentation, collecting/analyzing test data, and evaluating results against acceptance criteria.
  • •Experience using electronic laboratory equipment including digital multimeters (DMMs), oscilloscopes, power supplies, and hipot testers.
  • •Ability to interpret test requirements, troubleshoot failures, and recommend corrective actions; strong documentation, communication, and analytical/problem-solving skills.
Experience:2+ yearsMedical devicesProduct safety testingElectrical safety testingRegulatory compliance
Education:Bachelor's
Skills:Analytical skillsTroubleshootingProblem-solvingOrganizational skillsCommunication
Tech Stack:IEC 60601-1IEC 60601IEC 62368-1IEC 61010-1IEC 62133-2ISO 14971FDA guidanceTRFsTechnical Report FormsDigital multimeters (DMMs)OscilloscopesPower suppliesHipot testersElectrical safety testingProtective earth continuityInsulation resistanceDielectric strength (hipot)Leakage currentEngineering schematicsEngineering test reports

Company Brief

DEKA Research & Development
DEKA Research & Development is a private R&D and product development firm founded by Dean Kamen that designs and manufactures medical devices, mobility systems, energy and water solutions, and low-volume production prototypes for healthcare and industrial customers.
Industry: Medical Devices
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Manchester, United States
Founded: 1982
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