jazzhr
Product Safety Test Engineer
DEKA Research & Development
Manchester, USA
Full-time
Entry
Onsite
Discovered 1 weeks ago
Free
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- Interpret and apply product safety standards, including IEC 60601-1 and related standards, to DEKA medical devices and communicate requirements, risks, and recommendations to project teams.
- Provide technical guidance throughout product development to support compliance with applicable safety standards and regulatory requirements.
- Partner with cross-functional project teams to incorporate safety standards and risk management principles into product designs.
- Work with project teams to identify appropriate operating modes, configurations, and worst-case conditions for safety evaluations.
- Recommend investigational testing and design improvements to identify and resolve compliance issues early in the development process.
- Perform product safety testing in accordance with internal procedures and applicable standards, including test setup configuration, operation of laboratory instrumentation, electrical safety evaluations, data analysis, and assessment of compliance with applicable requirements.
- Accurately document test methods, test conditions, results, observations, and conclusions using good documentation practices.
- Develop, review, and execute product safety test plans, test cases, and compliance test reports.
- Support product failure investigations and root cause analyses by identifying safety compliance issues and recommending design modifications.
- Coordinate and oversee compliance testing performed by external accredited test laboratories when applicable.
- Prepare and support IEC 60601 Technical Report Forms (TRFs) and related documentation for regulatory submissions.
- Stay current with evolving FDA guidance, IEC standards, and other regulatory requirements applicable to DEKA products.
- Contribute to the continued improvement of the Product Safety Laboratory through improved test methods, expanded capabilities, and increased testing efficiency.
- Maintain laboratory equipment, calibration status, supplies, and a clean, organized, and safe working environment.
- Bachelor's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or a related engineering discipline preferred. Associate's degree in Electrical Engineering Technology or a related technical field with four (4) or more years of directly relevant experience will also be considered.
- Two years minimum experience performing hands-on product safety or electrical safety testing using established test methods, procedures, and applicable industry standards.
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