Principal Quality Engineer at Medtronic in Brooklyn Center, Minnesota

Job Description:

We anticipate the application window for this opening will close on - 15 Nov 2024

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
In this exciting and fast-paced role as a Principal Quality Engineer, you will have responsibility for providing quality engineering support for the manufacture of stacked plate battery components used in implantable medical devices. This position is located at the Medtronic Energy and Component Center (MECC) Battery Value Stream. The MECC facility supports the design, development, and production of numerous components used in implantable devices for a variety of Medtronic businesses.

The Principal Quality Engineer will serve as a subject matter expert for the quality engineering department in battery manufacturing.

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.

• Collaborates 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 Time Quality, Nonconformance reduction to address quality instabilities


• 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.


• Ensures 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.


• Develops, modifies, applies, and maintains quality standards and procedures.


• 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.


• 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, science or technical field with 7+ years of experience in quality and/or engineering OR Advanced Degree in Engineering, Science or technical field with 5+ years of experience in quality and/or engineering.

Nice to Have

• Working knowledge of ISO 13485, ISO 14971, 21CFR820.


• Experience in applying DMAIC / Lean Six Sigma principles; Green Belt or Black Belt certification.


• Good statistical data analysis skills, including SPC.


• Risk Management or CAPA experience.


• Experience in Automated Optical Inspection Validation.


• Excellent verbal and written communication skills.


• Ability to interface with internal customers, suppliers and external regulatory agencies.


• High attention to detail and accuracy.


• Medical device experience strongly preferred.


• Experience in the manufacturing of batteries, capacitors and other electrical components is a plus.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
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.

Salary ranges for U.S (excl. PR) locations (USD):$116,000.00 - $174,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

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.