Prin Software Design Quality Assurance Engineer- Embedded

Careers That Change Lives

The Principal Software Quality Engineer works as part of the core new product development team and sustaining to drive the software development activities for glucose sensing technology and automated insulin delivery systems to impact diabetics across the world. Solutions include insulin pumps, data-driven solutions mobile and web apps, and cloud infrastructure services.

In this role, you will be a part of a fast-paced cross-functional team that works with the latest generation of embedded solutions to maximize safety and minimize user burden.

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 is designed to provide customers greater freedom and better health, helping them achieve better glucose control while spending less time managing their disease.

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health, and extend life for millions of people worldwide.

Responsibilities may also include the following and other duties may be assigned:

1. Lead as a quality core/extended team member responsible for driving quality into the embedded software solutions in accordance with IEC 62304.
2. Lead the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D/Regulatory/Marketing/Operations.
3. 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.
4. Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review reports, test results, verification and validation reports, and defects.
5. Lead and conduct risk management activities including system risk analysis (ISO14971) and software FMEAs.
6. Lead and drive CAPA (Corrective and Preventative Action) projects.
7. Participate in both internal and external regulatory audits and inspections.
8. 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).
9. Define appropriate metrics to measure product quality and drive reliability.
10. Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
11. Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
12. Define appropriate measures to ensure product quality.
13. Develop overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
14. Ensure that projects and process control documentation are compliant with requirements, objectives, and/or contracts.
15. Review software systems design, change specifications, and plans against contractual and/or process requirements.
16. Reviews include applicable specifications, materials, tools, techniques, and methodologies.
17. Provide or direct verification and validation of software system requirements, traceability, and testability.