Why Join Medtronic?

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. You will be part of a dedicated, experienced, and high-performing team at our new Grand Rapids, MI site. At this facility, the assembler role is responsible for the day-to-day production and packaging of components used in our medical devices. You will be a key member of a manufacturing team that is dedicated to safety, quality, continuous improvement and achieving production goals. In the role you will be working in a clean room manufacturing environment that requires you to were personal protective equipment including eyewear, ear plugs, hair net and protective gowning.

Careers that change lives:

Engineers create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide.

In this exciting and fast-paced role as a Quality Engineer, you will have responsibility for providing quality engineering support for the manufacture of Cardiac Surgery devices. This position is located at the Medtronic manufacturing facility in Grand Rapids, MI. The Grand Rapids facility supports the production of devices used in extracorporeal therapy surgeries within the Cardiac Surgery operating unit of Medtronic. Key aspects of this role include leading and/or supporting quality investigations, review, and disposition of non-conforming product, establish statistical process controls, CAPA, collaborating with customer sites (downstream Medtronic facilities) on non-conformance investigation and resolution, and leading / supporting continuous improvement initiatives.

A Day in the Life

Responsibilities may include the following and other duties may be assigned:

• Collaborate with engineering and manufacturing functions to investigate and resolve quality or compliance issues discovered during operations.

• Provide product containment decisions for non-conformances; author and approve associated non-conforming product dispositions.

• Communicate significant issues identified during quality activities and recommend process improvements.

• Ensure assigned value stream is compliant with internal and/or external specifications, regulations and standards such as ISO.

• Lead and/or participate in statistical process control initiative and establishing a Key Point Indicator monitoring plan for manufacturing processes.

• Lead and/or participate in Continuous Improvement activities such as First Quality, Nonconformance reduction to address quality instabilities in support of Cell Operating System

• Lead and/or participate in corrective/preventive action teams in resolving production, customer and supplier issues (e.g., nonconformances, CAPA activities, audit findings)

• Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.

• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

• Interface and coordinate with other Medtronic facilities (e.g. downstream customer sites) to resolve issues and implement creative solutions.

• Support internal and external site audits and inspections.

• Review equipment and process validations, test method validation, process changes, nonconformances, etc., in order to ensure compliance and assess the impact on product reliability, process capability and compliance status.

• Develop, modify, apply, and maintain quality standards and procedures.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelors degree required

• 0 years of experience required

Nice to Have

• 2 years of quality engineering

• Experience with Medical Device manufacturing or other highly regulated industries

• Effective English verbal and written technical communication and presentation skills

• High attention to detail and accuracy

• Experience in Problem Solving / Root Cause Analysis

• Experience in technical writing

• Experience in Statistical Methods or Data Analysis

• ASQ CQE, CQA certification

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

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Min Salary

62400

Max Salary

93600

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.