Principal Software Quality Engineer - ENT
Medtronic
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 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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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, Tuition assistance/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
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
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 find here 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.