Senior Quality Engineer - Mounds View, MN at Medtronic in Mounds View, Minnesota

Job Description:

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.

Cardiac Rhythm Management offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. In this exciting role as a Senior Post-Market Quality Engineer, you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.

This position is in Mounds View, MN. within the Cardiac Rhythm Management (CRM) 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:

• Developing and maintaining files used to trend complaints to identify signals indicating potential emerging field issues.

• Collaborating with cross-functional teams to support emerging issues and complete in-depth investigations from field signals.

• Authoring Periodic Safety Update Reports (PSUR) and other periodic post market surveillance deliverables, including risk management file maintenance.

• Supporting business reviews and internal data requests.

• Ensuring that corrective measures meet acceptable reliability standards.

• May develop mathematical models to identify units, batches or processes posing excessive failure risks.

• As necessary, proposing changes to improve systems and/or processes.

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

• Working knowledge of data analytics and database development tools such as; Spotfire, Business Objects, Snowflake, SQL, SAS, Python

• Experience working within complaint management systems, including IMDRF Adverse Event Coding methodology.

• Knowledge of statistical best practices for complaint monitoring.

• Medical Device Industry experience or other regulated industry.

• Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 14971 and ISO 5841-2.

• Strong written and verbal communication skills and ability to work cooperatively as part of a cross functional team.

• Ability to manage project timelines to execute deliverables in a timely manner.

• Ability to solve problems and innovate solutions.

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-relatedknowledge, skills, and experience.