Quality Engineering Program Manager - Structural Heart and Aortic
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 in Medtronic, plc, we focus on providing Quality support across all aspects of PDP from premarket product development to post market product surveillance. We participate in the design process to ensure the performance and safety of the Structural Heart devices we develop, is assured and maintained throughout the product lifecycle. This position requires the successful candidate to be on site 4 days per week.
Come for a job, stay for a career!
A Day in The Life Of:
* Represent, lead, and be accountable for the functional group on the Core Team and participate in planning and execution of the project(s).
* Process requirements from multiple quality sub-function stakeholders and represent them 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 the 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 a FMECA and/or other risk management tools.
* Independently 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 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 producible and testable products.
* Apply understanding of anatomy & physiology with engineering knowledge in materials and processes to inform 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 organizations (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 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. A commitment to our employees lives at the core of our values with a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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 95,000+ passionate people. We are engineers at heart—putting ambitious ideas to work to generate real solutions for real people. Learn more about our business, mission, and commitment to diversity here.
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