We anticipate the application window for this opening will close on - 19 Aug 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

In this exciting role as a Principal Quality Engineer, you will have responsibility for manufacturing validation, quality systems, and product quality for new product and process development, and manufacturing site transfer at the Rice Creek Pharma Operations Manufacturing site in Fridley, MN.  The product portfolio includes new technologies and next-generation products in the combination drug/device product space.

Manufacturing Central Platform employs the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. The Manufacturing Central Platform offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. Rice Creek Pharma Operations, or Fridley, offers devices within defibrillation solutions, surgical infection control, and diabetes management portfolios.

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.

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 5 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.

• Develop, characterize, and validate medical device manufacturing processes.

• Provide guidance and knowledge on manufacturing process development and validation focusing on quality systems and combination product compliance (FDA 21 CFR Parts 210, 211, and 820).

• Collaborate with engineering and manufacturing functions to ensure the value stream complies with internal and/or external specifications, regulations, and standards such as ISO.

• Provide knowledge in quality assurance, specifically, cGMP, pharmaceutical manufacturing, API handling and controls, clean room environments, environmental controls and contamination.

• Review equipment, inspection, process validations, changes, etc., to ensure compliance and assess the impact on product reliability, process capability, and compliance status.

• Support activities required for combination product compliance and ensures activities are completed in parallel with development activities on time and budget.

• Employ First Time Quality mindset when developing manufacturing processes ensuring adequate controls are instilled in the process.

• Devise and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.

• Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to measure, monitor, improve, and control the manufacturing line and select processes.

• Guide and contributes to failure analysis and issue resolution activities to ensure corrective/preventative action is accomplished.

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

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

• Medical device, pharma, or drug-device combination products preferred.

• Experience with manufacturing execution systems.

• Experience with equipment and software validation.

• Strong written and verbal communication skills in English language.

• Comprehensive understanding of applicable Work Instructions, SOPs a