SW Design Quality Manager - Digital Products

Ensure you read the information regarding this opportunity thoroughly before making an application.

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

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 includes 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.

As a Software Design Quality Manager, you will lead the Software Design Quality team focused on Medtronic’s Digital portfolio (Mobile Apps, Cloud, etc.

You will be asked to manage and guide the design quality engineers in the pre-market design and sustaining space. You will be responsible for driving the development of safe, reliable, and compliant products / systems while working closely with 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.

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 action plans, applying organizational acumen appropriate for a senior level audience.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the 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 Digital and Cloud 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 Digital and Cloud 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.

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).

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 90,000+ 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.

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.

At Medtronic, most positions are posted on our career site for 3-7 days.

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