Sr Design Quality Engineer

Medtronic; Lafayette (CO); On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic in Lafayette, Colorado seeks a Senior Design Quality Engineer to drive product quality, reliability, and regulatory compliance across the ACM portfolio. You will partner with R&D, regulatory, manufacturing, and program teams to ensure design changes meet internal standards and global requirements.

This role emphasizes Design Controls, Risk Management per ISO 14971, verification and validation planning, and cross‑functional mentorship to advance safe, reliable medical devices.

Qualifications

• Experience in medical devices or regulated environments.
• Knowledge of ISO 13485, FDA 21 CFR 820, EU MDR.
• Experience applying ISO 14971 risk management.

Responsibilities

• Critically review designs for safety, reliability, and regulatory impact.
• Lead cross‑functional teams to implement design changes.
• Maintain and review risk management documentation (RM Plans, DFMEAs).
• Support verification and validation strategies, plans, and reports.
• Provide guidance on design controls and quality engineering practices.

Skills

Quality engineering

Cross-functional leadership

Regulatory compliance

Risk management

Design Controls

CAPA/root cause analysis

Problem solving

Education

Bachelor's Degree

Job description

Onsite

Lafayette, Colorado, United States of America

Full time

We anticipate the application window for this opening will close on - 18 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

The Senior Design Quality Engineer, supporting Released Product Engineering (RPE) within the Acute Care & Monitoring (ACM) Operating Unit, drives product quality, reliability, and regulatory compliance through technical expertise and cross‑functional leadership.

This role partners with R&D, regulatory, manufacturing, and program teams to ensure design changes and sustaining engineering activities meet internal quality standards and global regulatory requirements. The Senior Design Quality Engineer plays a critical role in applying Design Controls, Risk Management, and Change Control processes to evaluate, implement, and release product improvements across the ACM product portfolio.

If you are passionate about solving complex technical problems, improving product quality, and collaborating across disciplines to deliver safe and reliable medical devices, this role offers an opportunity to make meaningful impact.

Key Responsibilities:

• Critically review new and modified product designs to evaluate impact on product requirements, patient safety, reliability, and regulatory compliance.
• Ensure design changes are executed in accordance with Medtronic’s Quality Management System (QMS) and applicable global regulations including ISO 13485, EU MDR, and FDA Quality System Regulation (21 CFR Part 820).
• Lead cross-functional teams in the development and maintenance of risk management documentation including Risk Management Plans, hazard analyses, DFMEAs, and Risk Management Reports in accordance with ISO 14971.
• Support development and review of verification and validation strategies, including test plans, protocols, and reports, ensuring alignment with product requirements and applicable standards.
• Provide quality engineering support for sustaining engineering initiatives across multiple technical domains including electrical, software, mechanical, optical, algorithms, and human factors.
• Collaborate with cross-functional partners including R&D, Operations, Regulatory Affairs, Marketing, and Program Management to ensure timely and compliant execution of product changes.
• Apply Design for Reliability, Manufacturability, and Design for Six Sigma (DFSS) methodologies to improve product performance and reduce risk.
• Drive continuous improvement initiatives that enhance product quality, reliability, and manufacturing robustness.
• Provide technical guidance and mentorship to engineers on quality engineering principles, risk management practices, and design control requirements.

MUST HAVE: MINIMUM REQUIREMENTS:

EDUCATION REQUIRED:

• Bachelor’s Degree.

YEARS OF EXPERIENCE:

SENIOR LEVEL:

• 4+ years of Quality experience with a Bachelors Degree
• 2+ years of Quality experience with a Masters Degree

SPECIALIZED SKILLS OR EXPERIENCE:

• Experience in the medical device industry or in a regulated industry with similar quality and regulatory requirements
• Working knowledge of Quality Management Systems compliant with ISO 13485, FDA Quality System Regulation (21 CFR 820), and EU MDR
• Experience applying risk management processes in accordance with ISO 14971
• Familiarity with IEC 60601 and other applicable medical electrical equipment or product-specific standards
• Experience supporting design controls, verification and validation planning, and test execution for medical device products
• Experience with CAPA, root cause investigation, and failure analysis methodologies
• Technical experience with electronic hardware systems, including PCB design, schematics, circuit analysis, and PCB assembly documentation
• Demonstrated experience leading or owning complex technical problems or cross functional projects
• Strong written and verbal communication skills with the ability to work effectively across cross functional teams

NICE TO HAVE:

• ASQ certifications (CQE, CRE, CQA, etc.)
• Experience with statistical methods including hypothesis testing, ANOVA, GR&R, sampling plans, and parametric/non parametric analysis
• Experience using statistical software (Minitab or equivalent)
• Familiarity with reliability and environmental testing including HALT/HASS, shipping validation, sterilization, stability, or biocompatibility testing
• Experience with Lean, DMAIC, or DFSS methodologies
• Lean Six Sigma Green Belt or Black Belt

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):$98,400.00 - $147,600.00

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.

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 (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) 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.

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 to 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) .

For updates on job applications, please go to the candidate login page and sign in to check your application status.

If you need assistance completing your application please email [e-mail]

To request removal of your personal information from our systems please email [e-mail]