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Principal Software Design Quality Engineer
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Full-time
- Description: Abiomed, a part of Johnson & Johnson MedTech is recruiting for a Principal Software Design Quality Engineer located in Danvers, MA
- Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.
- This Principal Software Design Quality Engineer will have a focus on supporting the Software as a Medical Device (SaMD) projects at Abiomed.
- The engineer is responsible for various design quality engineering functions in support of development such as risk management, requirements and test reviews, as well as other design controls activities on Medical Device software.
- Lead Design Quality Engineering activities in support of Abiomed’s Software Product Development and Software Life Cycle processes for MDDS, CDS, IoT, Multi-function devices, and SaMD. This includes design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting
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