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

Cardiac Ablation Solutions (CAS) offers cardiac mapping and ablation solutions to treat patients with abnormal heart rhythms. Our vision is to help patients worldwide by advancing innovation for the diagnosis and ablation of cardiac arrhythmias, enabling clinicians to perform procedures with superior outcomes. Our team support the creation our market-leading portfolio of innovations.

The Senior Quality Engineering Manager represents Quality as the Quality Core Team  Representative (QCTM) and is the primary interface to the New Product Development & Operations Core team.  This is a highly visible and impactful role leading a global operations team responsible for shaping the manufacturing architecture to successfully develop and launch new products to meet cost, quality and supply goals for the business.

Come for a job, stay for a career!

A Day in The Life Of:

The Senior Quality Engineering Manager (QCTM) will provide program leadership to drive strategic and tactical quality activities related to  design, reliability and manufacturability (DRM).

Responsibilities may include the following and other duties may be assigned:

• Lead the Extended Operations Team comprising of Supply Management, Supplier Quality, Manufacturing Engineering, Process Development, Packaging and Supply Chain to ensure on-time and on-budget performance through the new product development cycle.
• Champion the Voice of Quality as well as drive planning and execution to ensure scope, schedule and budget alignment between operations and core team functions.
• Track and Manage Quality KPI’s
• Lead Design Transfer and Commercial Build Readiness to ensure quality system compliance to achieve production readiness and successful product launches.
• Manage CAPA execution, TMV development, statistical data analysis, and risk assessment
• Strong communicator with the ability to lead and Influence between Extended Operations Team and Core Team
• Coach and develop extended team members, to help individuals advance their skills and careers.  Provide performance feedback.
• Integrate Design for Reliability & Manufacturability (DRM) during product development as well as ensure structured problem methods and predictive engineering principles are consistently and rigorously applied.
• Skilled negotiator with demonstrated ability to create mutually beneficial results and negotiate trade-offs.
• Partner within the Operating Unit (OU) & Global Operations and supply chain (GO-SC) to grow and nurture cross functional & cross manufacturing site relationships in a large & matrixed organization.
• Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.

Key Skills & Experience  

Must Have: Minimum Requirements

• Bachelor’s degree in engineering/science or a related discipline
• Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience
• Experience as a Program Manager leading large scale new product development programs.
• Proven New Product Development Quality & Post Market Quality experience with depth of knowledge in at least two Operations functions.

Nice to Have

• Advanced degree in engineering/science or a related discipline
• Medical Device product development or operations experience with catheters, sheaths or other disposable medical devices.  Preference given to candidates who have FDA Class 3/PMA device experience.
• Program Management experience (PMP Certified), DRM, DFSS or Six Sigma Black Belt Certified

Medtronic offer a competitive salary and flexible Benefits Package

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Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer 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. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here