Product Safety Test Engineer

The Product Safety Test Engineer is responsible for evaluating the electrical safety of medical devices throughout the product development process. Working within DEKA's Product Safety Laboratory, this engineer partners with multidisciplinary design teams to identify compliance risks early, perform investigational testing, and provide technical guidance to support designs that meet applicable international safety standards. The role includes conducting formal compliance testing to IEC 60601 standards, supporting external certification activities, and preparing Technical Report Forms (TRFs) and other documentation for regulatory submissions. 

How you will make an impact as a Product Safety Test Engineer:

• 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. 

Skills you will need to be successful:

• 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. 
• Two years minimum experience configuring test setups, operating laboratory instrumentation, collecting and analyzing test data, and evaluating results against acceptance criteria. 
• Experience using common electronic laboratory equipment, including digital multimeters (DMMs), oscilloscopes, power supplies, hipot testers, and related instrumentation. 
• Ability to interpret test requirements, identify potential compliance issues, troubleshoot failures, and recommend appropriate corrective actions. 
• Experience interpreting engineering schematics, component specifications, and technical documentation to support compliance evaluations 
• Strong analytical, troubleshooting, and problem-solving skills. 
• Ability to work effectively within a multidisciplinary product development team. 
• Self-motivated with strong organizational and time management skills, including the ability to manage multiple projects and priorities. 
• Excellent verbal and written communication skills, including the ability to clearly document test methods, results, and engineering conclusions. 
• Ability to lift and move test equipment and medical devices weighing up to 35 pounds. 
• Ability to stand, walk, bend, reach, and kneel while setting up and performing laboratory testing. 

Preferred Skills:

• Experience evaluating medical devices in accordance with IEC 60601-1 and applicable collateral and particular standards. 
• Experience performing electrical safety testing, including protective earth continuity, insulation resistance, dielectric strength (hipot), leakage current, and other product safety evaluations. 
• Experience applying medical device risk management principles in accordance with ISO 14971, including hazard identification, risk analysis, risk controls, and verification of risk control measures. 
• Familiarity with FDA guidance, regulatory submissions, and documentation requirements for medical devices, including preparation of IEC 60601 Technical Report Forms (TRFs). 
• Understanding of electrical safety concepts, including insulation systems, creepage and clearance, isolation, transformers, grounding, and power electronics. 
• Experience interpreting engineering schematics, component specifications, and technical documentation to support compliance evaluations. 
• Experience applying industry standards such as IEC 62368-1, IEC 61010-1, IEC 62133-2, or other applicable product safety standards. 
• Experience preparing technical reports, compliance documentation, and engineering test reports. 

About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
 

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