Principal Software Design Assurance Engineer
📋 Role Overview & Responsibilities
Careers That Change Lives
The Principal Design Quality Assurance Engineer works as part of the core new product development product team to drive the software development activities for digital health solutions. Solutions include mobile applications, data driven solutions and infrastructure services. The candidate must possess an understanding of software development life cycle processes (waterfall/agile/DevOps) as applied within the regulated medical device industry. You will work with the core R&D team to drive quality into software product development for products such as CareLink. #MDTDiabetesReferralCampaign
DIABETES OPERATING UNIT
The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.
Engineers create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide.
A Day in the Life
Responsibilities may include the following and other duties may be assigned. Lead as a quality core team member responsible for driving quality into the design and development of software solutions (embedded integrated with medical mobile device applications (iOS/Android)/cloud technologies - AWS/IBM Watson)/data reports/AI/ML). Lead the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D/Regulatory/Marketing/Operations. Lead quality focused design and development of software within the software development lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability. Participate in design reviews for the system as well as 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 both internal and external regulatory audits and inspections. Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy).
Frequently Asked Questions
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This position is located in San Diego, CA with potential relocation and sponsorship assistance depending on candidate qualifications.
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