Senior Post Market Quality Program Manager

Careers that Change Lives

We value what makes you unique. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Senior Post Market Quality Program Manager is an exciting role within a rapidly growing business, leading several program management activities in Post Market Quality in support of business growth, new acquisitions, and business continuity within the Medtronic, Cardiac Ablation Solutions Operating Unit (CAS).

This role will have immediate organizational impact, owning key initiatives to expand the CAS business through recent acquisitions. The Senior Post Market Quality Program Manager will develop and drive strategies for managing short-term launch strategies with direct responsibility in establishing associated global CAS Returned Product Analysis Labs (RPA). In addition, this individual will lead the definition of the long-term RPA vision, driving consolidation to create efficient and consistent management of labs for rapidly growing product lines.

As part this role, this individual will have responsibility in establishing and maintaining lab requirements, driving equipment, resources, and overall budget for RPA labs associated with CAS acquisitions, business continuity, and business growth. The Senior Program Manager will be a key contributor to CAS success, owning an integrated part of program schedules, driving execution of RPA activities in alignment with new product launches and manufacturing transfers.

In addition, this role provides leadership and guidance within the Post Market Quality Issue Escalation process in leading teams and coordinating efforts for critical compliance decisions associated with clinical and market released products. As part of this role, this individual brings strong medical device industry Risk Management knowledge and compliance to ISO 14971, with ability to bring critical thought and its application within Design Controls and across the product life cycle.

This position is in Mounds View, MN.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life

In general, the following responsibilities apply for the Senior Post Market Quality Program Manager role. This includes, but is not limited to the following:

• Responsible for planning, initiating, monitoring, tracking and/or prioritizing engineering team's product development programs or projects and facilitating successful, on-time and within budget execution.
• Sets clear direction and management that aligns with defined practices and policies.
• Works closely with cross-functional teams to evaluate, develop and manage engineering projects
• Directs day to day activities for multiple work-stream teams through managing project plans, resourcing, status reporting, resolving issues, identifying project risks and accountability for deliverables across multiple functional organizations.
• Establishes meaningful metrics.
• Responsible for project performance, risk management, administration, financial management, budgeting, capital planning, forecasting and issue resolution.

MUST HAVE - MINIMUM REQUIREMENTS:

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

• Bachelor’s degree in Engineering, Science, or technical discipline
• Minimum of 5 years of experience in Quality and or Engineering or advanced degree with a minimum of 3 years of experience

Nice to Have

• Prior experience in medical devices or regulated environment
• Knowledge of heart anatomy and cardiac diseases (atrial fibrillation)
• Experience with the medical aspects of Atrial Fibrillation (AF) therapies, diagnostics, devices, and systems, including customer expectations, common medical practice, and systems troubleshooting
• Expert in risk management including international standards for risk management (ISO14971)
• Demonstrated ability to work in a matrix organization and positively influence strategy and outcomes.
• Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
• Understanding of the post-release market surveillance
  

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)