Medtronic is looking to solve the problem of ensuring the quality of software design and development for medical devices and related software products in the ENT (Ear, Nose, and Throat) operating unit.
Requirements
- Direct experience in software quality.
- Experience with medical device design controls, embedded systems, and hardware/software interactions.
- Experience with software development standards, including IEC 62304, IEC 81001, ISO 14971, ISO 13485.
- Proficiency in one or more programming languages: C/C++, C-Sharp, Linux/Unix, Python, and automated testing frameworks.
Responsibilities
- Develop, modify, and maintain standards for software systems quality operating methods, processes, and procedures.
- Conduct comprehensive evaluations of software system activities, including requirements, design, development, documentation, integration, testing, verification, and validation.
- Define and implement measures to ensure software quality, while developing and maintaining quality and reliability metrics.
- Work on software reliability controls, including reliability prediction and stress/performance testing.
- Ensure projects and process control documentation comply with requirements, objectives, and contracts.
Other
- ASQ CSQE or similar certifications.
- Flexibility and adaptability to work in a dynamic environment.
- Bachelor's degree in a relevant field (not explicitly mentioned but implied).
- Proven leadership experience in organizing and directing engineering teams.
