Software Quality Engineer

We anticipate the application window for this opening will close on - 12 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 LifeSoftware Quality Engineer for the HealthCast franchise in Acute Care and Monitoring focusing on new product development.
Design and deliver the medical device and supplies breakthroughs that make a difference in the lives of millions of patients.
Work with new product development teams to ensure that software used in the development, manufacture and as part of medical devices is developed and validated according to good design practices and requirements set forth by regulatory authorities. Help the development team by improving processes, through use of better tools, practices and automation, where applicable. Work with early technology teams to develop test strategies, methodologies and tools, where necessary.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.  ​

You Will:

• Be responsible for the quality of software products in the HealthCast portfolio.

• Learn the medical device industry requirements for quality systems, security, and software development and validation.  Provide guidance to teams to ensure that these requirements are met.

• Create risk management plans, perform product risk assessment, facilitate the failure mode effects analysis, and create final risk management reports.

• Generate strategies for measuring software reliability and security, develop metrics and evaluate results.

• Contribute to process improvements by identifying and validating better design tools, developing test strategies, methodologies and tools, where necessary.

• Participate in review of requirements, architecture, design, code and other work products with a focus on patient safety and device quality, testability, manufacturability, serviceability and security.

• Provide oversight of product software verification and manufacturing software validation processes.

• Oversee problem-tracking process and defect process resolution.

• Support outsourced software vendor audits and qualification, as required.

• Ensure that new product development and changes to existing products are conducted in compliance with the FDA Quality System Regulations and Medtronic internal processes.

• Learn statistical analysis techniques for determining sample size and analyzing test results.  Provide guidance to teams to ensure that statistically relevant and appropriate verification and validation testing is planned and completed.

• Review Design History Files and Technical Files for conformance to applicable requirements.

• Assist, when appropriate with internal, external, and supplier audits.

• Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.

Must Have:

Bachelors Degree and 0 years of experience required.

Nice to Have:

• Understanding of software programming techniques

• Ability to review and understand system and software architectural designs

• Good verbal (including presentation) and written communication skills

• Ability to effectively work on project teams.

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):$64,800.00 - $97,200.00

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.