We anticipate the application window for this opening will close on - 28 Jul 2025

 

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

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

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 molded components used in implantable medical devices. This position is located at the Medtronic Energy and Component Center (MECC) Connectors Focus Factory. The MECC facility supports the design, development, and production of numerous components used in implantable devices for a variety of Medtronic businesses. 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. 

Onsite

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 

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 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.

• 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 in your applicant profile. 

• Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality

Nice to Have  

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

• Injection Molding Experience

• Quality Lead Experience

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

• Good statistical data analysis skills, including SPC

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