Principal Quality Engineer

About this role

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life 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 onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

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.

Join us at Medtronic’s Boulder, Colorado facility - a dynamic hub for surgical innovations within our Medical Surgical portfolio. As a Principal Quality Engineer, you’ll play a pivotal role in advancing Medtronic’s mission: to alleviate pain, restore health, and extend life for patients around the world.

If you’re driven by challenge, energized by innovation, and passionate about making a real difference, this is your opportunity to be part of the next generation of life-changing medical technology. At Medtronic Boulder, your work will help shape the future of healthcare and positively impact patients’ lives every day. We invite you to join our team and make your mark on a healthier world.

The Principal Quality Engineer is a technical leader responsible for driving product and process quality across the product lifecycle. This role partners closely with engineering, manufacturing, operations, supplier quality, and other cross-functional teams to ensure robust quality systems, compliant products, and effective risk mitigation. The ideal candidate brings deep quality engineering expertise, strong problem-solving skills, and the ability to influence others in a fast-paced medical device environment. This role also plays a key part in identifying, assessing, and burndown of product and compliance risks by establishing long-term quality strategies and implementing sustainable controls that improve product robustness and regulatory compliance.                    

Responsibilities may include the following and other duties may be assigned. • Develops, implements, and maintains quality standards, procedures, and controls for products, processes, and associated documentation.

• Partners with engineering, manufacturing, operations, and supplier quality teams to identify, investigate, and resolve product and process quality issues.

• Leads root cause analysis, corrective and preventive action efforts, and effectiveness checks to ensure sustainable resolution of quality concerns.

• Identifies, prioritizes, and burndowns product and compliance risks by partnering with cross-functional teams to implement long-term mitigation strategies, strengthen controls, and ensure sustained quality and regulatory compliance.

• Designs and executes inspection, testing, validation, and verification strategies to ensure products and processes meet requirements and regulatory expectations.

• Analyzes quality data, trends, and nonconformances to identify risks, recommend improvements, and drive continuous improvement initiatives.

• Supports product development and process transfer activities by providing quality input on design controls, risk management, and process capability.

• Ensures quality system documentation is accurate, complete, and compliant with internal procedures and applicable regulatory requirements.

• Contributes to supplier and incoming material quality activities, including issue resolution, qualification support, and performance monitoring.

• Partners with leadership to evaluate quality impact, make data-driven decisions, and escalate significant issues as needed.

• May mentor and provide technical guidance to other quality engineers and cross-functional team members.

Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.

Nice to Have (Preferred Skills): • Experience in the medical device industry, preferably within surgical or highly regulated product environments

• Strong knowledge of quality systems, design controls, risk management, and CAPA processes

• Experience supporting product development, process validation, or manufacturing transfer activities

• Working knowledge of applicable regulatory standards and quality requirements, such as ISO 13485, FDA QSR, or IEC 62304 as applicable

• Experience with statistical analysis, data trending, and quality tools for decision-making and continuous improvement

• Demonstrated ability to influence cross-functional teams and communicate effectively across technical and non-technical groups

• Experience mentoring junior engineers or leading technical quality initiatives

• Six Sigma, Lean, or other continuous improvement experience

• Supplier quality and incoming inspection experience

• Strong problem-solving, root cause analysis, and troubleshooting skills

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being perform

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