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Principal Quality Engineer at Medtronic in Boulder
Job Description
Principal Quality Engineer
Location: Boulder, Colorado, United States of America · Onsite
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 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.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
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.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
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.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.