Software Quality Engineering Manager

We anticipate the application window for this opening will close on - 19 Apr 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 LifeBring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.

Join us for a career in Software Quality that changes lives.

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

• Plans, directs and implements all aspects of the company's software quality for new medical device products or software systems.
• Lead quality improvement projects to continuously enhance software quality operating methods, processes, and procedures (ISO13485, IEC62304, IEC82304, HIPAA, FDA, Security Standards, Data Privacy)
• Member of Software Change Control Board to manage changes post design freeze
• Expertise in system risk analysis and software FMEA to identify and mitigate risks, focusing on patient safety and adherence to regulatory compliance.
• Collaborate with R&D Engineering teams to review and implement best practices in software security, safeguarding patient data and product integrity.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Directs the software quality team in development and risk management of new concepts from initial design to market release.
• Manages the quality of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Functional manager role for software quality engineers focused on talent development, program execution, technical rigor, DRM practices and delivering on commitments to support the product portfolio.
• Active member of Quality Center of Excellence leadership team to drive strategic and tactical outcomes.

Must Have: Minimum Requirements

• BS degree and 5 years of Software Quality experience, or advanced degree with a minimum of 3 years prior Software Quality experience

Specialized Skills

• Software quality or development experience
• Significant breadth and depth in quality decision making, risk management, quality engineering, reliability engineering, requirements generation & testing, experimental modeling & simulation.
• Risk management experience in the medical device industry.
• Pre-Market Quality experience.
• Working knowledge of ISO13485, IEC62304, IEC62304, AAMI TIR45, HIPAA

Nice to Have:

• DRM Blackbelt Certification
• Experience with Robotic Systems
• Experience in SDLC environments using ALM tools (PTC Codebeamer, Atlassian Suite), defect tracking tools (Jira), and CI/CD tools (Gitlab, Jenkins).

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.
 

Salary ranges for U.S (excl. PR) locations (USD):$136,000.00 - $204,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

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.