Medtronic ENT is seeking a Principal Software Quality Engineer to ensure the quality of software design and development for medical devices and related software products, leading initiatives to advance existing technology and introduce new ones.
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, Linux/Unix, Python, and automated testing frameworks.
- Experience in applying software quality tools for static code analysis, code coverage, and code quality.
- Familiarity with product risk assessment, requirements management, defect tracking, configuration management techniques.
- Cybersecurity experience is a plus.
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.
- Review software systems design and change specifications against contractual and process requirements.
- Lead risk management activities, including system risk analysis (ISO 14971) and software risk management documentation (e.g., FMEA).
Other
- This position is based onsite in Jacksonville, FL.
- Formulate, deliver, and manage assigned projects, collaborating with cross-functional teams to achieve results.
- Mentor colleagues and guide lower-level professionals.
- Adhere to Quality System Practices as defined by Medtronic to ensure compliance with FDA, ISO, and European Medical Device quality standards.
- ASQ CSQE or similar certifications
