Senior Quality Engineer - Mounds View, MN
Senior Quality Engineer
Careers That Change Lives
At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
In this exciting role as a Senior Quality Engineer supporting the Coronary & Renal Denervation Quality organization, you will have responsibility for supporting Post Market Surveillance, Risk Management, and complaint investigations associated with the integration of the Medtronic Mounds View, MN. site.
Treatments We Offer:
Key Technologies
Symplicity Spyral™ Renal Denervation (RDN) System
This position is in Mounds View, MN within the Coronary & Renal Denervation (OHS) 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 Senior Quality Engineer role. This includes, but is not limited to the following:
· Performs complaint investigations and analyses of customer returns, documents test results, and supports the global complaint handling system.
· Completes trend analyses to ensure our products are meeting the expectation of the risk file.
· Leads introduction of new test methods, creation of fixturing, and validation.
· Supports engineering & supplier changes, executing reviews as a released Design Quality approver.
· Lead corrective/preventative actions (CAPAs), product hold orders (PHOs), field corrective actions (FCAs), and issue impact assessments (IIAs), as needed.
· Liaison with Customer Quality and Complaint Trending functions to assure coding is clear and robust.
· Owns departmental processes/activities including associated quality system documentation. As necessary, proposes changes to improve systems and/or processes.
· Work in a Returned Product Analysis (RPA) lab environment with product that has been previously used in a clinical setting (Personal protective equipment and training will be provided).
· Occasional travel within the USA and Internationally.
Must Have - Minimum Requirements
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
· Bachelor’s degree required in engineering, math, statistics, or a technical discipline
· Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Nice to Have
· Medical Device Industry experience.
· Strong written and verbal communication skills and work cooperatively as part of a team and cross functionally.
· Ability to manage project timelines to execute deliverables in a timely manner.
· Ability to solve problems and innovate solutions.
· Quality experience working in a regulated industry.
· Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
· Experience working within complaint management system.
· Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 10012, and ISO 17025.
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
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.
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.
