Lafayette, Colorado, United States of America, 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.
Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes across the globe.
Check us out on LinkedIn: Medtronic CST
A Day in the Life
The Senior Design Quality Engineer plays a critical role in ensuring product quality, safety, and regulatory compliance throughout the medical device product lifecycle, with a primary focus on product design, development, and sustaining engineering. As the quality representative on cross-functional project teams, you will provide technical leadership in design controls, risk management, verification and validation, and quality system compliance, partnering closely with Research & Development, Manufacturing, Regulatory Affairs, and Supply Chain to deliver safe, effective, and compliant medical technologies.
Responsibilities include, but are not limited to:
Serve as the Design Quality representative on new product development and sustaining engineering projects, ensuring compliance with design control and quality system requirements.
Lead design quality activities, including design controls, risk management (DFMEA, hazard analysis, risk controls), verification and validation strategies, and design traceability.
Review and approve design documentation, engineering changes, protocols, reports, and technical documentation to ensure product quality and regulatory compliance.
Partner with R&D and cross-functional teams to develop risk-based verification and validation strategies and assess the quality impact of design changes, nonconformances, and CAPA activities.
Support design transfer, supplier integration, manufacturing readiness, and product transfers to ensure successful commercialization and sustaining operations.
Collaborate with Engineering, Manufacturing, and Supplier Quality teams to establish inspection methods, testing strategies, and quality standards that ensure product reliability and performance.
Support internal and external regulatory inspections and audits, including FDA, ISO 13485, EU MDR, and other applicable regulatory requirements.
Provide technical quality leadership, influence cross-functional decision-making, and drive continuous improvement initiatives that enhance product quality, compliance, and operational excellence.
Location: Lafayette, CO (Onsite)
Onsite: At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This role will require <10% of travel to enhance collaboration and ensure successful completion of projects.
Minimum Requirement (Basic Qualifications):
To be considered for this position, the following Basic Qualifications must be evident on your resume
Bachelor’s degree in Engineering or Technical discipline with minimum of 4 years of relevant experience, OR
Master’s degree in Engineering or Technical discipline with minimum of 2 years of relevant experience, OR
PhD in Engineering or Technical discipline with minimum of 0 years of relevant experience.
Nice To Have (Preferred Qualifications):
Experience with FDA Quality System Regulation (QSR), ISO 13485, EU MDR, and medical device design control requirements.
Experience with Medtronic quality systems, design processes, or similar medical device quality management systems.
Experience supporting system-level medical devices, including capital equipment and associated accessories.
Knowledge of design transfer, supplier quality, manufacturing integration, labeling requirements, and regulatory submissions.
Strong analytical, collaboration, communication, and influencing skills, with the ability to lead cross-functional teams and drive quality decisions without direct authority.
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.
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.
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
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.