Prin Quality Engineer

Medtronic; Lafayette (CO); On-site; USD 121,000 - 181,000; Full time

Job summary

Medtronic in Lafayette, CO seeks a Principal Risk Management Quality Engineer to lead risk management, design controls, and regulatory compliance across the product lifecycle. This onsite role emphasizes collaboration in a fast paced medical device environment.

The ideal candidate will drive DFMEA, risk assessments, post‑market surveillance, and cross‑functional teamwork while ensuring patient safety and quality standards such as FDA and ISO 13485/14971 are met.

Qualifications

• Minimum bachelor’s degree in engineering or related field; advanced degree preferred.
• In-depth knowledge of FDA regulations, ISO 13485, ISO 14971 and other standards.
• Strong analytical and problem‑solving abilities; able to conduct root cause analysis.
• Excellent written and verbal communication; collaborate across functions.
• Proven leadership and project management skills with multi‑project workloads.

Responsibilities

• Develop and maintain risk management strategies and files.
• Lead hazard and risk analysis, DFMEA, and risk control implementation.
• Review product complaints and post‑market surveillance plans.
• Ensure traceability between risk management and design outputs.
• Coordinate with cross‑functional teams to ensure regulatory compliance and design reviews.

Skills

Quality engineering

Risk management

Regulatory compliance

Leadership

Problem solving

Communication

Education

Bachelor's degree in engineering

Advanced degree preferred

Job description

Onsite

Lafayette, Colorado, United States of America

North Haven, Connecticut, United States of America

Boston, Massachusetts, United States of America

Minneapolis, Minnesota, United States of America

Full time

R72635

We anticipate the application window for this opening will close on - 11 Sep 2026

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

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Principal Risk Management Quality Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team. The ideal candidate will have a strong background in risk management, product development, design controls and regulatory compliance within the medical device industry. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Principal Risk Management Quality Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team. The ideal candidate will have a strong background in risk management, product development, design controls and regulatory compliance within the medical device industry. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.

Key Responsibilities:

Develop and maintain comprehensive strategies for risk management activities, including:

• Collaborating cross-functionally to ensure the utmost product quality for patient safety

• Creating and maintaining the risk management file, including the risk management plans and reports, as well as conducting regular risk reviews.

• Leading hazard and risk analysis activities to identify potential risks and implement effective risk control measures.

• Leading Design Failure Modes and Effects Analyses (DFMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts.

• Analyzing and reviewing product complaints to anticipate and prevent future issues.

• Integrating product security measures to protect against potential vulnerabilities into the risk management file.

• Participating in Process FMEA/User FMEA development and integrating the Process FMEA/User FMEA into the risk management file.

• Leading design review and maintaining the risk management file throughout the product lifecycle

• Developing and managing post-market surveillance plans to monitor product performance and safety in the field.

• Leading field issue evaluation (including root cause analysis, risk evaluation, product containment strategy) during initial launch.

• Ensuring traceability between risk management file, requirements and design outputs utilizing a requirements management tool

• Evaluate the safety risk implications of design changes

Other potential responsibilities

• Lead and mentor teams in the development, implementation, and maintenance of the quality system processes and standards.

• Collaborate with cross-functional teams, to define and implement engineering and statistical processes that ensure product quality and compliance throughout the product lifecycle.

• Ensure compliance with relevant regulatory requirements, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participate in regulatory audits and inspections.

• Oversee design validation and design verification activities of user needs and design inputs, including the development of test plans, protocols, test methods and reports.

• Ensure thorough and accurate documentation including test results, risk assessments, and reports.

Qualifications:

Minimum Requirements:

• Education: Minimum bachelor’s degree in engineering, or a related technical field. Advanced degree is preferred

• Regulatory Knowledge: In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.

• Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.

• Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.

• Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.

Preferred Qualifications:

• Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.

• Experience: Regulated engineering field

• Industry Experience: Medical device industry.

• Technical Skills: Proficient in quality management systems, risk management, regulatory compliance, and statistics.

• Other: Basic knowledge of human anatomy/physiology and surgical procedures

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.

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.

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):$120,800.00 - $181,200.00

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).

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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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.

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 95,000+ 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.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life‑changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world

• Grow a career reflective of your passion and abilities

• Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need.

Life‑transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight‑driven care . Fresh viewpoints. Cutting‑edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here (https://www.e-verify.gov/employees) .

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