Careers That Change Lives

　　The Senior Design Quality Assurance Engineer works as part of the core new product development product and sustaining 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 medical devices and SaMD.

　　DIABETES OPERATING UNIT (bookmark://MEDTRONICOU_&) :

　　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/extended 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).

　　Define appropriate metrics to measure product quality and drive reliability.

　　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 in your applicant profile.

　　Bachelors Degree in Engineering, Science or Technical Field with 4+ years of experience in Engineering and/or Quality

　　OR

　　Advanced Degree in Engineering, Science or Technical Field with 2+ years of experience in Engineering and/or Quality

　　Nice to Have

　　Experience in software design and development, verification, validation and testing activities. [embedded software and/or 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).

　　Exposure to medical device compliance standards (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy).

　　Ability to author technical reports, business correspondence and standard operating procedures.

　　Exposure in data driven insight solutions leveraging machine learning/artificial intelligence (AI).

　　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.

　　Certified scrum master or SAFe or Black Belt or Green Belt or CQE preferred.

　　About Medtronic

　　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)

　　_A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits _ here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) _. _  

　　This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 _ _here .  

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　　The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.     

　　Min Salary

　　94400

　　Max Salary

　　141600

　　It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.