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
Quality Program Manager (QCTM) role in the SH&A OU for the Accessory Franchise program within our Structural Heart Design Assurance Group. This position requires on-site presence 4 days per week and supports all aspects of product development and post‑market product surveillance.
A Day in The Life Of:
* Represent, lead, and is accountable for the functional group on the Core Team and is an integral participant in the planning and execution of the project(s)
* Process requirements from multiple quality sub‑function stakeholders and represent in decision making
* Project‑manage functional tasks and deliverables per the project plan
* Proactively identify and manage project dependencies and risks
* Help establish program objectives, timelines, milestones, and budgets
* Provide input to functional manager on extended team member performance and development
* Apply knowledge of design control principles and quality engineering techniques throughout the product development process
* Identify and manage risk using FMECA or other risk management tools
* Lead investigations to identify system/product failures, hazards, hazardous situations, and harms
* Establish verification and validation strategies with R&D and Regulatory to assure an efficient approval path
* Develop master test plans that encompass design verification, design validation and process validation activities sufficient to meet regulatory requirements and quality objectives
* Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures to ensure products can be adequately manufactured and tested
* Apply understanding of anatomy & physiology with engineering knowledge in materials and processes to come up with design*
* Interface effectively and build relationships with team members, other staff and key technology and component suppliers locally and globally
Key Skills & Experience
* Requires a Level 8 degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
Preferred Qualifications
* Experience leading quality organization (QCTM) on new product development teams through commercialization, primarily catheter development
* Thorough understanding and experience in design controls, V&V, and Risk Management – both commercial and development
* System‑thinking and process mapping, ability to effectively identify interfaces, dependencies, and control points
* Demonstrated ability in stakeholder management and coordinating complex assignments with cross‑functional teams
* Understanding of 21CFR820, ISO13485, and ISO14971
* Experience owning or managing a QMS procedure/process
* Additional product Reliability responsibilities may include lean design tools (DRM), change management, and risk response
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). The benefits include medical, dental, vision, retirement, paid time off, and other competitive programs designed to support you at every career and life stage.
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 is to alleviate pain, restore health, and extend life. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people.
EEO Statement
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. This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees.
#J-18808-Ljbffr