The Role
Evaluates medical device electrical safety throughout product development. Responsibilities include interpreting IEC 60601 standards, advising design teams, configuring and conducting laboratory tests, analyzing results, investigating failures, documenting compliance findings, preparing test plans and technical reports, supporting external certification and regulatory submissions, and maintaining laboratory equipment. The role also applies risk management principles, coordinates multidisciplinary activities, and improves laboratory testing methods and efficiency.
Summary Generated by Built In
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:
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.
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.
- 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.
- 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.
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.
Skills Required
- Bachelor's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or a related engineering discipline
- Associate's degree in Electrical Engineering Technology or a related technical field with four or more years of directly relevant experience may be considered
- At least two years of experience performing hands-on product safety or electrical safety testing using established methods, procedures, and industry standards
- At least two years of experience configuring test setups, operating laboratory instrumentation, collecting and analyzing test data, and evaluating results against acceptance criteria
- Experience using digital multimeters, oscilloscopes, power supplies, hipot testers, and related electronic laboratory equipment
- Ability to interpret test requirements, identify compliance issues, troubleshoot failures, and recommend corrective actions
- Experience interpreting engineering schematics, component specifications, and technical documentation
- Strong analytical, troubleshooting, and problem-solving skills
- Ability to work effectively within a multidisciplinary product development team
- Strong organizational and time management skills, including managing multiple projects and priorities
- Excellent verbal and written communication skills, including documenting 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
- Experience evaluating medical devices in accordance with IEC 60601-1 and related collateral and particular standards
- Experience performing electrical safety testing, including protective earth continuity, insulation resistance, dielectric strength, and leakage current
- Experience applying medical device risk management principles under ISO 14971
- Familiarity with FDA guidance, regulatory submissions, and IEC 60601 Technical Report Forms
- Understanding of insulation systems, creepage and clearance, isolation, transformers, grounding, and power electronics
- Experience applying IEC 62368-1, IEC 61010-1, IEC 62133-2, or other product safety standards
- Experience preparing technical reports, compliance documentation, and engineering test reports
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The Company
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
