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 as a Product Safety Test Engineer:

• 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:

• 3+ years’ experience in a Test Engineer role with Product Safety- related experience preferred

• 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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