Design Quality Engineer II

Job description

We anticipate the application window for this opening will close on - 28 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 Position Description The Design Quality Engineer II, supporting Released Product Engineering (RPE) within the Acute Care & Monitoring (ACM) Operating Unit, contributes to product quality, reliability, and regulatory compliance through quality engineering support for sustaining engineering and product change activities. This role partners with R&D, Regulatory Affairs, Manufacturing, Operations, and Program teams to help ensure design changes and released product engineering activities are executed in accordance with Medtronic’s Quality Management System (QMS), applicable standards, and global regulatory requirements. The Design Quality Engineer II applies Design Controls, Risk Management, and Change Control processes to support evaluation, implementation, and release of product improvements across the ACM product portfolio. If you are passionate about solving technical problems, improving product quality, and collaborating across functions to support safe and reliable medical devices, this role offers an opportunity to make meaningful impact while continuing to grow your design quality engineering expertise. Key ResponsibilitiesReview new and modified product designs to help assess impact to product requirements, patient safety, reliability, standards compliance, and regulatory requirements. Support design change activities in accordance with Medtronic’s QMS and applicable global regulations and standards, including ISO 13485, EU MDR, and FDA Quality System Regulation / QMSR expectations. Support the development and maintenance of risk management documentation, including Risk Management Plans, hazard analyses, DFMEAs, risk assessments, and Risk Management Reports in accordance with ISO 14971. Review and provide input to verification and validation strategies, test plans, protocols, reports, and supporting documentation to help ensure alignment with product requirements and applicable standards. Provide quality engineering support for sustaining engineering initiatives across technical disciplines such as electrical, software, mechanical, optical, algorithms, human factors, and data analysis. Collaborate with cross-functional partners including R&D, Operations, Regulatory Affairs, Marketing, Manufacturing, and Program Management to support timely and compliant execution of product changes. Support investigations, issue evaluation, CAPA activities, root cause analysis, and failure analysis as needed for released product quality concerns. Apply quality engineering tools and problem-solving methods to help identify risks, evaluate data, and support product and process improvements. Contribute to continuous improvement initiatives that enhance product quality, reliability, manufacturability, and compliance. Communicate technical and quality information clearly through documentation, review comments, meetings, and cross-functional collaboration. Basic QualificationsBachelor’s degree in Engineering, Science, or a related technical discipline and a minimum of 2 years of relevant Engineering, Quality, or regulated industry experience; or an advanced degree with relevant academic, project, internship, or industry experience. Specialized Skills or ExperienceRequired / Strongly Preferred for SuccessExperience in the medical device industry or another regulated industry with similar quality and regulatory requirements. Working knowledge of Quality Management Systems and regulated product development or sustaining engineering processes. Familiarity with ISO 13485, FDA Quality System Regulation / QMSR expectations, EU MDR, or other applicable medical device regulatory frameworks. Familiarity with risk management principles, including ISO 14971, hazard analysis, FMEA, or risk-benefit documentation. Experience supporting design controls, verification and validation activities, design changes, or product lifecycle documentation. Ability to review technical documentation and assess potential quality, safety, reliability, and compliance impacts. Experience supporting CAPA, root cause investigation, nonconformance evaluation, issue assessment, or failure analysis. Strong written and verbal communication skills with the ability to work effectively across cross-functional teams. Demonstrated ability to manage assigned tasks, document decisions clearly, and escalate issues appropriately. Nice to HaveMedical device design quality, sustaining engineering, released product engineering, or product development experience. Experience with electronic hardware systems, PCB assemblies, schematics, circuit analysis, or related technical documentation. Familiarity with IEC 60601 or other applicable medical electrical equipment/product-specific standards. Experience with statistical methods such as hypothesis testing, ANOVA, GR&R, sampling plans, or parametric/non-parametric analysis. Experience using statistical software such as Minitab or equivalent. Familiarity with reliability or environmental testing, including HALT/HASS, shipping validation, stability, sterilization, or biocompatibility testing. Experience with Lean, DMAIC, DFSS, or structured problem-solving methodologies. ASQ certification such as CQE, CRE, CQA, or equivalent quality certification. Lean Six Sigma Green Belt or Black Belt. About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations — but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Physical Job RequirementsThe 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 required responsibilities and skills. The physical demands described within the Day in the Life section of the 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. DisclaimerThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. 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