Principal SW Design Quality Assurance Engineer

4 weeks ago


San Diego, California, United States Medtronic Full time
About the Role

We are seeking a highly skilled Principal SW Design Quality Assurance Engineer to join our team at Medtronic. As a key member of our core new product development product team, you will drive software development activities for digital health solutions, including mobile applications, data-driven solutions, and infrastructure services.

The ideal candidate will possess a deep understanding of software development life cycle processes, including waterfall, agile, and DevOps, as applied within the regulated medical device industry. You will work closely with our core R&D team to drive quality into software product development for products such as CareLink.

Key Responsibilities

  • Lead as a quality core team member responsible for driving quality into the design and development of software solutions
  • Collaborate with cross-functional teams, including R&D, Regulatory, Marketing, and Operations, to develop and implement quality strategies
  • Participate in design reviews and review and approve design input/design output artifacts, including requirements, design documents, code review, test results, verification and validation reports, and defects
  • Lead and conduct risk management activities, including system risk analysis and software FMEA's
  • Lead and drive CAPA (Corrective and Preventative Action) projects
  • Participate in internal and external regulatory audits and inspections
  • Lead quality improvement projects to include compliance standards for software quality, operating methods, processes, and procedures

Requirements

  • Bachelor's Degree in Engineering, Science, or Technical Field with 7+ years of experience in Engineering and/or Quality
  • OR, Advanced Degree in Engineering, Science, or Technical Field with 5+ years of experience in Engineering and/or Quality
  • Experience in software design and development, verification, validation, and testing activities
  • Experience executing in the SDLC environment leveraging ALM tools, defect tracking tools, development tools, test tools, and CI/CD tools
  • Exposure to medical device compliance standards, including ISO13485, IEC62304, HIPAA, FDA, Security Standards, and Data Privacy

What We Offer

  • Competitive salary and flexible benefits package
  • Opportunity to work on cutting-edge medical technology
  • Collaborative and dynamic work environment
  • Professional development and growth opportunities

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