We anticipate the application window for this opening will close on - 11 Apr 2025
Position Description:
Sr. Software Design Quality Assurance Engineer for Medtronic, Inc. Minneapolis, MN. Support new product development group to drive the software development activities for digital health solutions. Responsible for mobile applications, data driven solutions and infrastructure services. Collaborate with core R&D to drive quality into software product development for products including Digital Health mobile apps and cloud-based systems such as CareLink. Engage 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)/cloud technologies - AWS/AI/ML). Responsible for quality strategy for projects in alignment with business goals for cross-functional teams including R&D / Regulatory / Marketing / Operations. Drive quality focused design and development of SDLC software within the software development lifecycle (Agile/waterfall/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability. Participate in design reviews for the system for the review and approval of design input/design output artifacts including requirements, design documents, code review, test results, verification and validation reports and defects. Conduct risk activities including system risk analysis and software FMEAs. Drive CAPA (Corrective and Preventative Action) projects while participating in both internal and external regulatory audits and inspections. Drive quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures including ISO13485, IEC62304, HIPAA, FDA, Security Standards, and Data Privacy. *Multiple positions available. **Position is open to telecommuting from anywhere in the United States. *** Employer will accept any suitable combination of education, training or experience. #LI-DNI.
Basic Qualifications:
Master’s degree in Chemistry, Computer Science, Computer Engineering, Software Engineering, or related engineering field and three (3) years of experience with mobile application development and testing. Experience must include three (3) years of post-Bachelor’s progressive experience in all of the following: Design and development of digital health solutions for medical mobile device applications (iOS/Android), cloud technologies – AWS and AI/ML; Working with R&D, Regulatory, Marketing, and Operations to ensure product quality and alignment with business goals; Design and development of software within the SDLC (software development lifecycle) including Agile, waterfall & DevOps by defining requirements, design, verification and validation plan and strategies while maintaining traceability; Design reviews for the system to include review and approval of design input/design output artifacts including requirements, design documents, code review, test results. Verification and validation reports and defects; Risk activities including system risk analysis and software FMEAs; CAPA and participating in internal and external regulatory audits and inspections; Quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures including ISO13485, IEC62304, HIPAA, FDA, Security Standards, and Data Privacy.
Alternate Qualifications:
Bachelor’s degree in Chemistry, Computer Science, Computer Engineering, Software Engineering or related engineering field and five (5) years of experience with mobile application development and testing. Experience must include five (5) years of post-Bachelor’s progressive experience in all of the following: Design and development of digital health solutions for medical mobile device applications (iOS/Android), cloud technologies – AWS and AI/ML; Working with R&D, Regulatory, Marketing, and Operations to ensure product quality and alignment with business goals; Design and development of software within the SDLC (software development lifecycle) including Agile, waterfall & DevOps by defining requirements, design, verification and validation plan and strategies while maintaining traceability; Design reviews for the system to include review and approval of design input/design output artifacts including requirements, design documents, code review, test results. Verification and validation reports and defects; Risk activities including system risk analysis and software FMEAs; CAPA and participating in internal and external regulatory audits and inspections; Quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures including ISO13485, IEC62304, HIPAA, FDA, Security Standards, and Data Privacy.
The position reports to Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432 and is open to telecommuting from anywhere in the United States.
Salary: $141,900 to $147,600 per year
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below: Medtronic benefits and compensation plans
Top Skills
What We Do
Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions.
Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year.
To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.
