Medtronic is looking to improve patient outcomes in ear, nose, and throat health by developing innovative solutions, and this role will contribute to that goal by ensuring the quality of software design and development for medical devices.
Requirements
- Experience with medical device design controls, embedded devices, hardware and software interactions
- Experience in software development standards (IEC 62304, IEC 81001, ISO 14971, ISO 13485)
- Experience in test automation during new product development
- Experience in one or more of the following areas: C/C++, C-Sharp, Linux/Unix, Python, automated testing frameworks
- Demonstrated knowledge in scripting languages (e.g. PowerShell, Python, Bash) and relevant numerical libraries
- Understanding and appreciation of SDLC process and tools (e.g. Azure DevOps, JIRA, Bitbucket, Stash, Confluence, JAMA, Git, CMake)
- Experience in effectively applying software quality tools for static code analysis, code coverage, code quality, etc.
Responsibilities
- 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 software quality
- Works on software reliability controls including reliability prediction, stress and performance testing for software
- Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives
- Reviews software systems design, change specifications, and plans against contractual and/or process requirements
- Lead and conduct risk management activities including system risk analysis (ISO14971) and software risk management documentation
Other
- Bachelors degree required in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or a technical field
- Minimum of 7 years of technical experience, or advanced degree with 5 years of technical experience
- Flexible and adaptable, comfortable working in a dynamic environment
- Proven leadership experience organizing and directing engineering teams
- Autonomy: Recognized expert, managing large projects or processes
- Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results
