Engineering Manager - Software Design Quality (Embedded Products)

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.