Posted in General Business 30+ days ago.
This job brought to you by eQuest
Location: Plymouth, Minnesota
Careers that Change Lives
In this exciting role as a Sr Operations Quality Engineer you will directly support the day-to-day manufacturing of APV products at our Plymouth, MN facility. You will have the opportunity to drive a culture of continuous improvement by deploying sound engineering fundamentals to achieve quality objectives and ultimately yielding better patient outcomes.
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
AORTIC AND PERIPHERAL offers treatment for vascular abdominal and thoracic aortic disease and interventional devices used to treat Peripheral Artery Disease (PAD) through catheter-based procedures and diagnostic technologies.
A Day in the Life
Day-to-Day responsibilities may include the following and other duties may be assigned.
- Supports or leads large-scale projects within the site.
- Provide mentorship to the quality and manufacturing functions in the proper use of engineering fundamentals.
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished
or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of
products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs
statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet
required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory
control and/or research and development as they apply to product or process quality.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors Degree in Engineering or Science field with 2+ years of experience in Engineering and/or Quality OR Masters Degree in Engineering or Science field with 0+ years of experience in Engineering and/or Quality.
Nice to Have
- Strong understanding of process validation principles, including experience with master validation plans, installation qualifications, operational qualifications, process qualifications, and test method validations.
- Sound understanding of statistical techniques, including but not limited to gage R&R studies, process capability, analysis of variance (ANOVA), design of experiments (DOE), and control charting.
- Understanding of Corrective and Preventative Actions (CAPAs), ideally having been a CAPA owner.
- Ability to effectively solve problems; experience using DMAIC methodology.
- Six Sigma Green Belt or Black Belt certification.
- Understanding of medical device Risk Management tools, particularly the Process Failure Modes and Effects Analysis (pFMEA).
- Understanding of what comprises a Device Master Record.
- Experience with change control, both as an approver and change owner.
- General awareness of the product lifecycle process.
- Awareness of lean principles.
- Demonstration of self-motivation.
- Ability to effectively manage large-scale projects.
- Effective communication skills.
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)
Ability to travel up to 10% domestic and international.