We anticipate the application window for this opening will close on - 25 Feb 2025

 

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 Post Market Quality Senior Engineering Manager, you will lead the Aortic Post Market Product Assurance and Quality Sustaining team based in Santa Rosa, CA for all commercial Aortic products for our Structural Heart and Aortic business.

• Manages a team of Reliability Engineers that are responsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product
• Manage a team responsible for all Design Assurance activities supporting changes to commercial products.
• Coach team members through technical problem solving including CAPA investigations and triaging issues. 
• Provide technical knowledge and input into risk assessments when quality issues are being evaluated.
• Provide front room support during inspections from regulatory agencies (e.g. FDA, FDB, Notified Body).
• Manage performance and develop talent to support a high performing team and culture.
• 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.
• Create strategic plans for driving efficiencies, improving competencies, and developing people to continuously improve function.
• Provide oversight and expertise in design change control and risk management activities.

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

• Bachelor’s degree
• Minimum 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.

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 Aortic 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 representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific