Careers That Change Lives

Medtronic leads the health care industry to provide solutions that benefit the daily lives of people across the globe. Our organization contributes directly to this mission through our rich software system, which include Embedded products, Mobile and Cloud based applications combined with scaled infrastructure and advanced analytics. Become part of our team and you will be challenged to build these amazing software products, and in the process, make a real difference. #MDTDiabetesReferralCampaign

As a Software Design Quality Manager, you will lead the Software Design Quality team focused on Medtronic’s Embedded device portfolio, you will be asked to manage and guide the design quality engineers in the pre-market design and sustaining space. You will be responsible to drive development of safe, reliable, and compliant products/systems while working very closely with the cross functional teams and building a highly technical and competitive design quality engineers.

The best candidates will be critical thinkers, problem solvers, strong executers, self-driven with strong leadership skills & hands-on management approach. Strong relationship skills are a must, as is excellent verbal and written communication.

A Day in the Life

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

Plans, directs, and implements all quality aspects of the company's design and development of new and sustaining medical device products or software systems, with detailed focus on software reliability, risk management and patient safety.
Provide oversight and training in the application of work processes to ensure successful adoption by development teams and positive, measurable results obtained from development programs.
Work closely with cross functional teams and quality peers to ensure project planning is complete end-to-end, for both pre-market and post-market activities.
Manages activities to assure programs are appropriately resourced and ensure continuous improvement in technical capability, process, and compliance.
Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Communicate program status using clear metrics and specific actions plans, applying organizational acumen appropriate for a senior level audience.
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Working knowledge of IEC 62304, 21 CFR 820.30 and ISO 14971
Manages feasibility studies of the design to determine if capable of functioning as intended.
Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

Bachelor’s degree required in Engineering, Science or technical field with 5+ years of experience in the embedded software medical device space and 5 years of technical leadership or managerial experience.

OR

Advanced Degree in Engineering, Science or technical field with 3+ years of experience in the embedded software medical device space and 5 years of technical leadership or managerial experience.

Nice to Have

Direct experience in software, or systems engineering in a design engineering role.
Extensive experience in complex product development projects with strong knowledge of product development in regulated industries (such as medical device, healthcare, aerospace, or transportation industries)
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD/EU MDR.
Ability to author technical reports, business correspondence and standard operating procedures.
Experience in applying metrics to measure and improve processes and product quality during product development.
Proven track record of success in leading cross functional efforts in work process improvement.
Experience in influencing, educating, and fostering others in adopting work practices.
Strong employment history of assuming successive organizational roles with increasing responsibility.

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)

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. Learn more about our benefits here.

This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.  

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