Principal Software Design Quality Assurance Engineer
8 hours ago
We are seeking a highly skilled Principal Software Design Quality Assurance Engineer to join our team at Medtronic. As a key member of our core new product development product team, you will drive the software development activities for digital health solutions, including mobile applications, data-driven solutions, and infrastructure services.
The ideal candidate will possess a deep understanding of software development life cycle processes, including waterfall, agile, and DevOps, as applied within the regulated medical device industry. You will work closely with our core R&D team to drive quality into software product development for products such as CareLink.
Responsibilities- Lead as a quality core team member responsible for driving quality into the design and development of software solutions.
- Collaborate with cross-functional teams, including R&D, Regulatory, Marketing, and Operations, to develop and implement quality strategies.
- Develop and maintain quality-focused design and development of software within the software development lifecycle.
- Participate in design reviews and approve design input/design output artifacts, including requirements, design documents, code review, test results, and verification and validation reports.
- 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 internal and external regulatory audits and inspections.
- Lead quality improvement projects to ensure compliance with software quality operating methods, processes, and procedures.
- Bachelor's 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.
- Experience in software design and development, verification, validation, and testing activities.
- Experience executing in the SDLC environment leveraging ALM tools, defect tracking tools, development tools, test tools, and CI/CD tools.
- Exposure to medical device compliance standards, including ISO13485, IEC62304, HIPAA, FDA, Security Standards, and Data Privacy.
- Ability to author technical reports, business correspondence, and standard operating procedures.
- Exposure to data-driven insight solutions leveraging machine learning and artificial intelligence.
- Exposure to wireless communication protocols.
- Exposure to n-tier architecture models and/or experience with ITIL processes/IT systems.
- Working knowledge of integrated digital health systems, including consumer products.
- Certified Scrum Master or SAFe or Black Belt or Green Belt or CQE preferred.
The 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.
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.
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San Diego, California, United States Medtronic Full timeAbout the RoleWe are seeking a highly skilled Principal Software Design Quality Assurance Engineer to join our team at Medtronic. As a key member of our core new product development product team, you will drive software development activities for digital health solutions, including mobile applications, data-driven solutions, and infrastructure services.Key...
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San Diego, California, United States Medtronic Full timeAbout the RoleWe are seeking a highly skilled Principal Software Design Quality Assurance Engineer to join our team at Medtronic. As a key member of our software development team, you will be responsible for driving quality into the design and development of software solutions.Key ResponsibilitiesLead the collaborative quality strategy for projects in...
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San Diego, California, United States Medtronic Full timeAbout the RoleWe are seeking a highly skilled Principal SW Design Quality Assurance Engineer to join our team at Medtronic. As a key member of our core new product development product team, you will drive the software development activities for digital health solutions, including mobile applications, data-driven solutions, and infrastructure services.Key...
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