Medtronic Sr Quality Engineer in Louisville, Colorado
Sr Quality Engineer
Rice Creek, Minnesota, United States
Feb 19, 2021
Careers That Change Lives
In this exciting role as a Senior Quality Engineer, Manufacturing Transfer, CoE you will have responsibility for providing leadership and technical support for MT projects, helping to properly understand the scope, technical complexity, risks, financial and resource requirements, as well as, requalification efforts associated with MTs.
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a trusted partner means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
A Day in the Life:
Quality Engineering within Manufacturing Transfer (MT) Center of Expertise will apply a robust, standard methodology for conducting manufacturing site transfers across the enterprise to enhance the safety, quality, service impact, and cost profile of transfers.
The Quality MT Engineer may be assigned as a core team member to MTs or may play an advisory role depending on the transfer.
The Quality MT Engineer will also help identify best practices and define standard work to be utilized in MT projects.
They will partner effectively with cross-functional teams that include specialists from Manufacturing, Regulatory Affairs, Product Development, Sourcing, and Finance to help develop, execute, and drive MT projects.
Execute projects within the constraints of budget, timeline, resource constraints, and project performance requirements.
Strong understanding of DHF requirements, manufacturing processes and equipment within Med Device Manufacturing, validation methodology, finance, budgeting, and CAR requirements/processes, as well as supply chain and supplier quality.
Engage stakeholders of multiple functions to keep abreast of changing priorities within the transfer landscape.
Fosters an environment of collaboration with cross-functional team members by focusing on continuous improvement.
Take on role as MT SME to train and teach others in the network on best practices.
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 4+ years of work experience in Engineering and/or Quality in a regulated industry OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality in a regulated industry
Nice to Have:
Preferred degrees include Mechanical Engineering, Electrical Engineering, Materials Engineering, Biomedical Engineering, or a similar related engineering or science field.
Experience in manufacturing or manufacturing support such as manufacturing engineering, quality engineering, supplier quality engineering, or similar.
Notified body, supplier, or other similar audit experience helpful.
Advance degree beneficial.
Previous work in a regulated environment such as Medical or Aerospace.
Previous direct experience with manufacturing transfers.
PMP Certification, or previous work experience with Project Management.
Green Belt Certification inLean Six-Sigma, DRM or similar.
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. Lets 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 Requirements Up to 25% travel, with the ability to travel internationally .
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.