Engineering Program Manager (QCTM) - Mounds View, MN
MedtronicAbout the role
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
Careers That Change LivesA career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. In this exciting leadership role as a Engineering Program Manager you will have responsibility for representing the entire Quality function as the Quality Core Team Member on cross-functional product development initiatives for the Cardiac Rhythm Management (CRM) Operating Unit (OU).You will be empowered to establish Quality and Reliability strategy early in design for new product development. In this rewarding role, you can directly influence product quality outcomes across new product development programs.
A Day in the Life Responsibilities may include the following and other duties may be assigned:
Plans, directs, and implements all aspects of the company's design and development of new medical device products and systems.
May develop, evaluate, implement, and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
Oversees the investigation and evaluation of existing technologies.
Guides the conceptualization of new methodologies, materials, machines, processes, or products.
Directs the development of new concepts from initial design to market release.
Manages feasibility studies of the design to determine if capable of functioning as intended.
Monitors documentation maintenance throughout all phases of research and development.
Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
Develop Quality functional strategies, plans, and schedules to meet project goals and manage risks.
Maintain alignment and manage execution across global Quality disciplines.
Communicate key program information to ensure Core Team and Quality leadership engagement and alignment.
Plan and manage program resource allocation and budget.
Drive functional excellence, lessons-learned, and business and quality management system improvement.
Represent Voice of Quality across all global Quality disciplines.
Ensure quality requests are defined, implemented, and met (requests flow down) across project.
Establish and maintain close relationships with Operations Quality at sites to develop and communicate project strategies and identify issues.
Proactively drive and champion strategic quality, reliability, and safety improvements
Identify quality risks and implement risk burn down strategies.
Ensure an effective transfer to global Post-Market Quality functions.
Coordinate project support for audits.
Must Have: Minimum Requirements: To be considered for this role, please ensure the minimum requirements are evident on your resume.
Requires a Bachelor's Degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
Nice to Have:
7+ years relevant engineering experience with implantable medical products
1-2+ years management experience.
Master’s degree in engineering, science, or business
Working knowledge of multiple quality disciplines, especially reliability, safety and compliance
Quality or reliability engineering experience in product development
Experienced practitioner of Design for Reliability and Manufacturability (DRM)
Knowledge and experience with Lean Sigma tools
Knowledge and experience of product development processes and design controls
Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and to drug-device combinations.
Physical Job Requirements:
The physical deman
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