Medtronic Engineering Director - Mounds View, MN in Mounds View, Minnesota
Careers that Change Lives
We value what makes you unique. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
In this exciting role as a Post-Market Quality Engineering Director, you will have responsibility for managing the post-market quality operations for the Mechanical Circulatory Support Operating Unit (MCS OU). This role leads the reliability engineering, complaint investigation, and failure analysis lab teams. The Post-Market Quality Engineering Director directly contributes to patient safety by managing quality issue resolution including managing relationships with our customers and regulators for the MCS product portfolio. This role works closely with design, manufacturing operations quality and supplier quality teams. The Quality Engineering Director also plays a key role in strategy and planning for the MCS OU.
The Mechanical Circulatory Support Operating Unit is responsible for Medtronic’s heart pump program. Called the HeartWare™ HVAD™ System, this business provides a left ventricular assist device (LVAD) that helps patients’ hearts pump and increases the amount of blood that circulates through their bodies. The HVAD System features the world's smallest, commercially available, centrifugal flow pump.
This position is in Mounds View, MN. within the Mechanical Circulatory Support (MCS) operating unit and requires on-site presence three days a week.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
A Day in the Life
In general, the following responsibilities apply for the E ngineering Director role. This includes, but is not limited to the following:
· Leads post-market strategy for the MCS OU including direct engagement with OU senior staff and the MCS Independent Practitioner Quality Panel.
· Oversees risk assessments and the product risk management files. Includes decision making on product holds and managing field corrective actions where appropriate.
· Serves as the voice of quality engineering on the MCS CAPA Board.
· Supports internal and external audits.
· Ensures effective and timely returned product investigation in the failure analysis lab. Escalates new and unique product quality signals and investigation status to OU senior staff.
· Regularly interfaces with US FDA and global regulators to communicate post-market strategy, respond to MDR and Part 806 questions, and ensure timely responses to requests for additional information.
· Selects, develops and evaluates personnel to ensure the efficient operation of the function.
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, and/or Quality
· Minimum of 10 years of relevant experience in Engineering and/or Quality with 7 years of managerial experience, OR advanced degree in Engineering, and/or Quality with a minimum of 8 years of relevant experience with 7 years of managerial experience
Nice to Have
· Front-room and back-room FDA audit experience.
· Experience in manufacturing a Class III active implantable medical device.
· Pre or post market quality experience with risk assessments and/or risk management files.
· Experience responding to audit observations and resolution of Warning Letter or other regulatory enforcement actions.
· Experience in the execution of field corrective actions
· Experience in Manufacturing engineering and/or manufacturing quality engineering
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)
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. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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