Job Title: Principal Design Quality Assurance Engineer (Digital Health Solutions - Mobile Applications)
Req Number 220005I5
Location: Northridge, CA (Los Angeles, CA) or Remote within the US
Careers That Change Lives
The Principal Design Quality Assurance Engineer works as part of the core new product development team 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 latest digital technologies including mobile apps, cloud technologies and data drive AI/ML 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 are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.
A Day in the Life
* Lead as a quality core team member responsible for driving quality into the design and development of digital health solutions (medical mobile device applications (iOS/Android).
* 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).
Responsibilities may also include the following and other duties may be assigned.
* Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
* Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
* Defines appropriate measures to ensure product quality.
* Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
* Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
* Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
* Reviews include applicable specifications, materials, tools, techniques, and methodologies.
* Provides or directs verification and validation of software system requirements, traceability, and testability.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors Degree in Engineering, Science or Technical Field with 7+ years of experience in Engineering, Software and/or Quality OR Advanced Degree Engineering, Science or Technical Field with 5+ years of experience in Engineering, Software and/or Quality
Nice to Have (Preferred Qualifications)
* Experience in software design, development, verification, validation and testing activities. [mobile application development [(Java (objective-C), and Kotlin (Swift)) and/or cloud infrastructure services (such as Amazon AWS/Microsoft Azure/IBM Watson).
* Experience executing in the SDLC environment leveraging ALM tools (Eg: PTC Integrity/Atlassian Suite/TFS), defect tracking tools (Eg:Jira), development tools (Git, SourceTree, Android Studio, GitLab), test tools (Selenium/JUnit), CI/CD tools (Jenkins).
* Ability to author technical reports, business correspondence and standard operating procedures.
* Exposure in mobile application design, development, DevOps and testing using tools such as TestFlight.
* Exposure to data driven insight solutions leveraging machine learning/artificial intelligence (AI) and cloud technologies.
* Exposure with wireless communication protocols (Eg: Bluetooth).
* Exposure to n-tier architecture models and/or experience with ITIL processes/IT systems.
* Working knowledge of integrated digital health systems including consumer products such as Apple Inc./Android products.
* Exposure to medical device compliance standards (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy).
* Certified scrum master or SAFe or Black Belt or Green Belt or CQE preferred.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Travel less than 25%