Principal Software Design Quality Engineer

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.

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 aPrin.Software Quality Engineer. This position is basedonsitein Jacksonville, FL.

In this role, you will serve as an individual contributor with responsibilities in our technical functions to advance existing technology or introducenew technologiesand 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 tonew technologiesor therapies—from design to implementation—while adhering to policies,utilizingspecialized 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 willfacilitatethe 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, andmaintainsstandards for software systems quality operating methods, processes, and procedures.

Develops,modifies, applies, andmaintainsstandards for software systems quality operating methods, processes, and procedures.

• Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test,verificationand validation.

Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test,verificationand validation.

• Definesappropriate measuresto ensuresoftwarequality.Develops andmaintainsquality and reliability metrics.

Definesappropriate measuresto ensuresoftwarequality.Develops andmaintainsquality and reliability metrics.

• Workson software reliability controlsincludingreliability prediction,stressandperformance testing for software.

Workson software reliability controlsincludingreliability prediction,stressandperformance testing for software.

• Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements andobjectives.

Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements andobjectives.

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

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

• Reviews software systems design,changespecifications, and plans against contractual and/or process requirements.

Reviews software systems design,changespecifications, 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.

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 reviewcybersecurity documents such as SBOM, STRIDE analysis andPenetration testing.

Participate and reviewcybersecurity documents such as SBOM, STRIDE analysis andPenetration testing.

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

Follow all Quality System Practices as defined by Medtronic Navigation’s practices,policiesand 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.

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

• Bachelorsdegreerequiredin Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or a technical field.

Bachelorsdegreerequiredin Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or a technical field.

• Minimum of7years of technical experience,

Minimum of7years of technical experience,

• Oradvanceddegree with5years of technical experience.

Oradvanceddegree with5years of technical experience.

• Experience with medical device design controls, embedded devices,hardwareand software interactions

Experience with medical device design controls, embedded devices,hardwareand software interactions

• Experience in software developmentstandards(IEC 62304,IEC 81001,ISO 14971, ISO 13485) preferred

Experience in software developmentstandards(IEC 62304,IEC 81001,ISO 14971, ISO 13485) preferred

• Experience in test automation during new product development

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

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

Demonstrated knowledgeable in scripting languages (e.g.PowerShell, Python, Bash) and relevant numerical libraries

• Understanding and appreciation of SDLCprocessand tools (e.g.Azure DevOps,JIRA, Bitbucket, Stash, Confluence, JAMA, Git,CMake.)

Understanding and appreciation of SDLCprocessand 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 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

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

Proven leadership experience organizing and directing engineering teams

• Flexible and adaptable, comfortable working in a dynamic environment

Flexible and adaptable, comfortable working in a dynamic environment

• Cybersecurity experience is desirable

Cybersecurity experience is desirable

DIFFERENTIATING FACTORS

Recognized expert, managing large projects or processes. Exercises considerable latitude indeterminingdeliverables of assignments, with limited oversight from manager. Coaches,reviewsand delegates work tolower levelspecialists.

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 ofimmediatejob area. Innovation and Problems and issues faced are difficult, moderatelycomplexand undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvementsofprocesses,systemsor products independently to enhanceperformance of job area. Implements solutions to problems.

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

Typically provides guidance, coaching and training to other employees withinjobarea. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

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 description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuitionassistance/reimbursement , and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:

Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

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It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.