Sr Quality Engineering Manager at Medtronic in Santa Ana, California

Job Description:

Sr Quality Engineering Manager
Req Number 21000RFT
Location Santa Ana, CA

Careers That Change Lives

The Senior Quality Engineering Manager is a leadership position responsible for driving world-class quality and reliability through the released product management (RPM) and product development process (PDP) in one of Medical device's fastest growing therapies. The primary focus of this position is the management of marketed products, managing a team of global engineers, execution to business priorities, and cross functional support. Activities include enabling engineering support to failure investigations, CAPA processes, reg body queries, significant product or process changes, iterations, QS metric deliverables and resolution of quality issues in addition to facilitating change management improvement initiatives. This position will also provide support to the Product Development side of the business with a strong emphasis on design assurance for the design and development, transfer and commercial release of new products.

Structural Heart and Aortic

The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves-aortic, pulmonic, mitral, tricuspid-and the placement of stent grafts to treat aneurysms and dissections of the body's largest artery, the aorta

A Day in the Life

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

Together with the pre-market quality team and Research & Development, create/manage a technically rigorous and efficient released product management quality group that consistently enables product performance management and influence to the development teams on design considerations.

Includes the following elements:
• Functional manager for a team of global engineers and technicians
• Support for post-market risk management
• Manages post-market short term deliverables e.g. complaint analysis, requests from global reg bodies.
• Manage career developmental needs of team in order to meet individuals and organizational objectives
• Provide timely and constructive feedback on job performance
• Identify and hire talent to meet short- and long-term organizational objectives
• Assessment and implementation of risk management process and tools
• Manage robust data monitoring program to include analysis, trending, issue escalation, and reporting
• Compliance to worldwide quality system design control and risk management requirements
• Support for internal and external audits at multiple sites
• Support for regulatory submission preparation, internal QC & review and agency question responses
• Create and manage AOP for the local QA function
• Determines and implements best practice structure and methodologies for the group
• Active member of the CAPA Board
• Periodically serve as an independent reviewer for PDP

Responsibilities may also include the following and other duties may be assigned.

• Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
• May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.

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

Bachelors Degree in Engineering, Science or technical field with 7+ years of experience in Quality and/or Engineering with 5+ years of leadership OR Advanced Degree in Engineering, Science or technical field with 5+ years of experience in Quality and/or Engineering with 5+ years of leadership.

Nice to Have (Preferred Qualifications)

• 5+ years of experience providing work direction and leadership to people and teams
• Bio prosthesis experience. Heart Valves a significant advantage.
• Demonstrated ability to successfully provide technical direction and communicate technical risks and opportunities within areas of limited information.
• Ability to perform well in cross-functional development teams.
• Extensive experience with advanced statistical methods: SPC, DOE, ANOVA and others Extensive experience with product development, design verification, validation, risk management
• Ability to flex as a hybrid manager i.e. performing engineering activities when required

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 to each role. (ADA-United States of America)

• Travel 10% U.S. & International

Additional Information

• Posting Date: Oct 15, 2021
• Travel: No