Product Safety Test Engineer
Product Safety Test Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 rootcause 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
- Selfmotivated and able to selfprioritize
- 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 623681 IEC 621332 and 610101
- Experience with technical writing
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 cuttingedge technology into the modern age.
Behind DEKAs 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 lifechanging products of our time are created and new ideas are always welcome and explored.
Required Experience:
Manager
Employment Type
Full-Time
