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Sr. Software Design Quality Assurance Engineer
| Company | Medtronic |
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| Location | Minneapolis, MN, USA |
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| Salary | $141900 – $147600 |
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| Type | Full-Time |
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| Degrees | Master’s |
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| Experience Level | Senior |
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Requirements
- 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.
Responsibilities
- 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.
Preferred 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.
