Product Safety Test Engineer
DEKA
- Manchester, NH
- Permanent
- Full-time
- 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
- 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