We anticipate the application window for this opening will close on - 29 Nov 2024

 

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 Lives

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 Sr. Pre-Market Quality Engineering Manager in Cardiac Surgery (CS), you will lead the Cardiac Surgery Pre-Market Design Assurance Engineering team based in Brooklyn Park, Mounds View, and Dexter Michigan.

This team includes design assurance engineers supporting pre-market and sustaining, quality core team members, supplier quality assurance, software quality assurance and people manager.

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

• Lead Pre-Market Quality including Support new product development and released product engineering, pre-initiation quality input for staffing/strategy, support Quality Strategy for new projects, Support Risk Management architecture/etc developed by engineers, Support DRM targets (challenging how/why they are set the way they are), Support Design and Phase reviews/ PRC, Support Design Transfer, Support Audit support for Design Controls, Approve all RM documents, design phase reviews
• Responsible for budget of team (project charging), enter actuals and planned FTE’s through AOP process
• Provide direct supervision, coaching and mentoring to the design assurance engineers, quality core team members and people manager in your team.  This includes work direction, priority and objective setting, development opportunities, training, and performance management.
• Plans, directs and implements quality related aspects of the company's design and development of new products within the portfolio. Ensures compliance in development processes.
• May develop, evaluate, implement and maintain technical quality assurance and control systems and standards pertaining to materials, techniques, or company products including ensuring a thorough connection between design controls deliverables (from design planning, requirements development, risk management, design verification/ validation through design transfer) in the DHF to process validation, production and process controls and content captured in the DHR.
• Collaborate with R&D engineering, our product management organization and partner engineering teams in making product design decisions.
• Drive establishment of Quality, Reliability, and product development strategies to improve safety, reliability, and usability of the product family for our patients.
• Partner with RD on development of test strategies
• Ensures risk management processes are fully integrated into development processes and support production and process controls.
• Drives alignment between pre and post market quality teams, ensuring seamless transfers to production.
• Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations
• 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 BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

• Bachelor’s degree in engineering, science or a technical discipline
• Minimum of 7 years of relevant expe