We anticipate the application window for this opening will close on - 26 Sep 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Principal Software Quality Engineer

Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. We focus on providing innovative solutions for ENT conditions, including surgical and therapeutic products designed to improve patient outcomes in ear, nose, and throat health.

We are currently offering an excellent opportunity to join the ENT Quality team as a Principal Software Quality Engineer. This position is based onsite in Jacksonville, FL.

Role Overview

In this role, you will serve as an individual contributor responsible for ensuring the quality of software design and development for medical devices and related software products. As a Principal Software Quality Engineer, you will lead initiatives that advance existing technology and introduce new technologies and therapies. You will formulate, deliver, and manage assigned projects, collaborating with cross-functional teams to achieve results. Your expertise in software quality engineering will be critical in mentoring colleagues and guiding lower-level professionals.

Key Responsibilities

• Quality Standards Development: Develop, modify, and maintain standards for software systems quality operating methods, processes, and procedures.
• Software Evaluation: Conduct comprehensive evaluations of software system activities, including requirements, design, development, documentation, integration, testing, verification, and validation.
• Quality Assurance Measures: Define and implement measures to ensure software quality, while developing and maintaining quality and reliability metrics.
• Reliability Controls: Work on software reliability controls, including reliability prediction and stress/performance testing.
• Compliance Oversight: Ensure projects and process control documentation comply with requirements, objectives, and contracts.
• Design Review: Review software systems design and change specifications against contractual and process requirements.
• Risk Management: Lead risk management activities, including system risk analysis (ISO 14971) and software risk management documentation (e.g., FMEA).
• Cybersecurity Participation: Participate in and review cybersecurity documentation, including SBOM, STRIDE analysis, and penetration testing.
• Quality System Practices: Adhere to Quality System Practices as defined by Medtronic to ensure compliance with FDA, ISO, and European Medical Device quality standards.
• Verification and Validation: Provide or direct verification and validation of software system requirements, ensuring traceability and testability.

To Be Successful in This Role

• 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.

Nice to Have

• 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.
• Proven leadership experience in organizing and directing engineering teams.
• Flexibility and adaptability to work in a dynamic environment.
• Cybersecurity experience is a plus.
• ASQ CSQE or similar certifications

 

Physical Job Requirements

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. 

The physical demands described within the Responsibilities section of this job descripti