Prin. Software Design Quality Engineer 

Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. The unit focuses 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 Prin. Software Quality Engineer. This position is based onsite in Jacksonville, FL. 

In this role, you will serve as an individual contributor with responsibilities in our technical functions to advance existing technology or introduce new technologies and therapies. You will be tasked with formulating, delivering, and managing assigned projects, collaborating with other stakeholders to achieve desired results. You may mentor colleagues or direct the work of lower-level professionals. Your primary focus will be on delivering research and development, systems, or initiatives related to new technologies or therapies—from design to implementation—while adhering to policies, utilizing specialized knowledge and skills, and continuously improving products and processes. This position involves providing design quality engineering support for the software design and development of medical devices, stand-alone software of non-products, non-devices, and components, including firmware. Additionally, you will facilitate the application of design controls in product development and released product management. 

Responsibilities may include the following, and other duties may be assigned. 

• 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. Develops and maintains quality and reliability metrics. 

• 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.  

• Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. 

• 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, including system level risk management reviews, Failure Mode and Effects Analysis, product risk assessments and assessing specific product issues for impact to patient and/or user safety. 

• Participate and review cybersecurity documents such as SBOM, STRIDE analysis and Penetration testing.  

• Follow all Quality System Practices as defined by Medtronic Navigation’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.  

• Provides or directs verification and validation of software system requirements, traceability, and testability.  

Must Have: Minimum Requirements 

• 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. 

To be considered for this role, please ensure the minimum requirements are evident on your resume. 

Nice to Have 

• 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) preferred 

• Experience in test automation during new product development 

• Experience in one or more of the following areas: C/C++, C#, Linux/Unix, Python, automated testing frameworks 

• Demonstrated knowledgeable 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. 

• Experience in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle 

• Proven leadership experience organizing and directing engineering teams 

• Flexible and adaptable, comfortable working in a dynamic environment 

• Cybersecurity experience is desirable 

DIFFERENTIATING FACTORS  

Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.  

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. May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.  

Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates May negotiate with others to reach understanding or agreement, and influence decision-making.  

Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.