Senior Design Quality Engineer - CST - Fort Worth, TX (Onsite)
Medtronic · Fort Worth, Texas, United States of America
Job description
We anticipate the application window for this opening will close on - 8 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: In this exciting role as a Senior Design Quality Engineer, you will partner with cross-functional teams to ensure quality is integrated throughout the product development lifecycle, from concept through commercialization and sustaining engineering. You will work closely with R&D, Regulatory, Clinical, Operations, and Manufacturing to support Design Quality execution, risk management, design verification and validation, and compliant product development. This role plays a critical part in ensuring products meet quality, regulatory, and customer requirements while supporting continuous product improvements and successful design transfers to manufacturing. Key Responsibilities: Partner with cross-functional teams to integrate Design Quality requirements into product development and lifecycle management activities. Support Design Quality execution from concept through commercialization, design changes, and sustaining engineering. Contribute to risk management activities, including risk identification, assessment, mitigation, and traceability throughout product development. Support design verification and validation activities to ensure products meet quality, safety, and regulatory requirements. Develop and maintain objective evidence, design documentation, and Design History File (DHF) records to support compliant product development. Apply quality system and regulatory requirements to design changes, product modifications, and lifecycle management activities. Support design transfer activities by partnering with Operations and Manufacturing to ensure quality requirements are effectively implemented. Develop, apply, and maintain quality standards, inspection methods, testing protocols, and quality documentation. Collaborate with Engineering and Manufacturing to establish quality processes and ensure product and process compliance. Perform quality analysis, inspection planning, statistical analysis, and support corrective and preventive actions to improve product quality and reliability. Support quality activities involving suppliers, externally developed components, and manufacturing processes to ensure compliance with applicable standards. Location: Fort Worth, TX (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: Bachelor’s degree in Engineering or Technical field with minimum of 4 years of relevant experience, OR Master’s degree in Engineering or Technical field with minimum of 2 years of relevant experience, OR PhD with 0 years of relevant experience Nice to Have (Preferred Qualifications): Experience in medical device or other highly regulated industry. Experience supporting combination products, including drug delivery systems, biologics, or other combination device technologies. Experience with product lifecycle management, sustaining engineering, and design changes Knowledge of Design Controls, Design Verification & Validation (V&V), and Risk Management (ISO 14971). Familiarity with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and global medical device regulations. Exposure to Design History Files (DHF), traceability, and technical documentation. Experience with statistical analysis, root cause investigations, and quality improvement methodologies. Experience supporting design transfer and manufacturing readiness activities. Strong cross-functional collaboration skills with R&D, Regulatory, Clinical, Operations, and Manufacturing 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 & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment
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