Product Safety Test Engineer

Manchester, NH

Full Time

Product Safety

Mid Level

Looking for an experienced Product Safety Engineer to evaluate medical devices within our Product Safety Lab. The lab has full capability to test to the IEC 60601-1 and its related collateral standards. There is internal EMC capability as well. This person will support device design teams during concept and development with technical input and preliminary testing. Towards the end of development IEC 60601 TRFs will need to be generated for inclusion in an FDA 510k submittal.

How you will make an impact:

Work closely with project teams to become familiar with the operation and intended use of the medical devices being evaluated
Collaborate with project teams to steer product designs and risk management approach toward standards compliance
Provide design support during all phases of development and recommend appropriate investigational testing and design changes
Understand and interpret safety standards as they apply to DEKA devices and communicate to the project team
Author/review test cases and compliance test reports
Work with project teams to determine applicable operating and configuration modes for evaluation and testing
Conduct testing using internal work instructions and test standards
Record test data using good documentation practices
Contribute to design failure investigations and root-cause analyses as needed, making recommendations for design changes needed for compliance
Coordinate and oversee testing with contract test laboratories
Participate in the continued improvement of the Product Safety Lab including better efficiency and the expansion into new standards and test methods
Keep current with the latest FDA Guidelines and standards as they apply to DEKA devices
Maintain test equipment, lab supplies and a clean workspace

Skills you will need to be successful in this role:

1 – 2 years of experience in a laboratory setting
BS degree in electrical, biomedical, mechanical engineering or other relevant field
Experience with general lab equipment such as DMM, oscilloscopes, and power supplies
Ability to work as part of an interdisciplinary team
Self-motivated and able to self-prioritize
Ability to clearly communicate verbally and in writing
Preferred Skills:
- Familiarity with IEC 60601 collateral and particular standards
- Experience with Risk Management and ISO 14971
- Proficiency in electrical circuit analysis with an understanding of transformers, insulation and power electronics
- Experience with applying knowledge of industry standards such as IEC 62368-1, IEC 62133-2, and 61010-1
- Experience with technical writing

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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