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

A 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 role as a Post Market Quality Engineering Director in Cardiac Surgery (CS), you will lead the Cardiac Surgery Post Market Product Assurance team based in Brooklyn Park, Mounds View, and Santa Ana, including surgical/mechanical valves and ECT products.

Cardiac Surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac Operating Room by offering an unparalleled depth and breadth of portfolio. Key Technologies:

• Surgical heart valves
• Cardiac OR solutions (e.g., blood management, cannulae)
• Extracorporeal life support
• Coronary artery bypass grafting (CABG) solutions

• Manages a team of Reliability Engineers that are responsible for monitoring product performance, complaint investigations and evaluating quality issues impacting released product
• Coaches team members through technical, logistical, and problem solving and resolution including technical CAPA investigation and action phases. 
• Provide technical knowledge and input into Issue Impact Assessments when quality issues are being evaluated for risk.
• Provide front room support during inspections from regulatory agencies (e.g. FDA, FDB, Notified Body).
• Manage performance, develop talent, engagement and inclusion, communicate business and operational developments, plan, prioritize and/or direct the responsibilities of direct reports.
• Demonstrate the ability to communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management.
• Accountable for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

Must Have: Minimum Requirements: To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree
• Minimum 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience.

Nice to Have

• Bio-medical engineering degree
• Prior experience in or demonstrated strong working knowledge of global medical device regulations and requirements.
• Experience dealing directly with U.S. FDA and/or other medical product competent authorities/regulatory authorities.
• Engineering experience with medical devices, specifically disposable devices.
• Thorough working knowledge of medical device industry product risk management regulations and standards
• Understanding of heart anatomy and human/blood physiology
• Demonstrated perfusion product application knowledge
• Strong communication skills (written, verbal, listening (with all levels of the organization). Strong interpersonal, and problem-solving skills.
• Experience supporting cross-functional and cross-regional teams in a matrixed org. developing collaborative relationships.
• Identifies and resolves issues in a proactive, creative, and timely fashion.

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