Medtronic
Principal SW Design Quality Engineer - Digital Products
Medtronic, San Diego, California, United States, 92189
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the LifeThe Principal SW 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.
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 LifeResponsibilitiesResponsibilities 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).
Must Have: Minimum Requirements
Bachelors 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.
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.
Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package. 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.
Salary ranges for U.S (excl. PR) locations (USD): $119,200.00 - $178,800.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
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.
#J-18808-Ljbffr
A Day in the LifeThe Principal SW 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.
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 LifeResponsibilitiesResponsibilities 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).
Must Have: Minimum Requirements
Bachelors 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.
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.
Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package. 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.
Salary ranges for U.S (excl. PR) locations (USD): $119,200.00 - $178,800.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
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.
#J-18808-Ljbffr