Senior Quality Engineer – CST – Lafayette, CO (Onsite)

Job description

We anticipate the application window for this opening will close on - 1 Aug 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 As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. 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 This position is not eligible for immigration sponsorship. Applicants must be authorized to work in the country of employment without sponsorship. A Day in the Life As a Senior Quality Engineer, you will provide quality engineering leadership supporting commercial evaluation programs and operational quality initiatives across the CST portfolio. This role partners closely with Operations, Technical Services, Project Coordinators, Marketing, Regulatory Affairs, and Quality Systems to ensure compliance with Medtronic Quality System requirements while enabling business objectives. You will serve as a key quality representative responsible for CAPA investigations, audit readiness, process improvements, quality system compliance, and operational oversight of commercial evaluation programs, capital equipment management, servicing and preventative maintenance activities, and field evaluation processes. Your work will directly contribute to maintaining product quality, regulatory compliance, and operational excellence while supporting innovative technologies that improve patient care. Responsibilities include, but are not limited to: Serve as the Quality Engineering representative supporting commercial evaluation programs and operational quality initiatives across the Cranial & Spinal Technologies portfolio. Provide quality leadership by ensuring compliance with Medtronic Quality System requirements, regulatory expectations, and business objectives. Lead complex CAPA investigations, nonconformance investigations, audit responses, and continuous improvement initiatives using risk-based problem-solving and root cause analysis. Partner cross-functionally with Operations, Engineering, Technical Services, Marketing, Regulatory Affairs, and Quality Systems to implement sustainable quality solutions. Develop and maintain quality standards, procedures, documentation, and traceability systems that support inspection readiness and operational excellence. Collaborate with Engineering and Manufacturing to establish inspection methods, testing strategies, and quality standards that ensure product reliability and process effectiveness. Support quality oversight for commercial evaluation programs, capital equipment management, field servicing, preventative maintenance, and product traceability. Support internal and external regulatory inspections and audits while ensuring corrective actions meet reliability, quality, and compliance requirements. 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 (21 CFR Part 820), ISO 13485, EU MDR, and medical device quality systems. Demonstrated experience leading CAPA investigations, root cause analysis, audit support, and continuous improvement initiatives. Experience supporting commercial operations, field evaluation programs, capital equipment, or technical service quality within the medical device industry. Knowledge of manufacturing quality, supplier quality, inspection methods, process validation, and product reliability. Strong cross-functional collaboration, communication, and influencing skills, with the ability to drive quality decisions across diverse teams. 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 & Compen