Quality Engineer II

We anticipate the application window for this opening will close on - 12 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 Peripheral Vascular Health (PVH) Operating Unit brings together a broad portfolio of peripheral vascular technologies, products, and services to address the needs of clinicians and patients worldwide. This organization partners across engineering, manufacturing, quality, and operations functions to support product performance, process excellence, and continuous improvement throughout the product lifecycle. This position is based at the Plymouth Nathan Lane facility in Plymouth, Minnesota and supports sustaining and project quality engineering initiatives across manufacturing operations. This is an onsite role with limited travel requirements. As a Quality Engineer II, you will serve as the quality representative for sustaining and strategic manufacturing projects within the Peripheral Vascular Health business. This role partners with cross-functional stakeholders to support process improvements, ensure compliance with quality system requirements, drive manufacturing performance, and provide technical leadership for quality engineering initiatives. Primary Responsibilities Serve as the quality engineering representative on manufacturing and operational improvement projects, ensuring quality requirements are incorporated into project planning and execution. Analyze manufacturing and quality data using statistical and problem-solving methodologies to identify root causes, develop corrective actions, and monitor effectiveness. Execute quality engineering deliverables, including risk assessments, equipment and process qualifications, validations, and technical documentation. Review and approve process changes, product dispositions, corrective and preventive actions (CAPA), and quality system documentation. Develop and implement solutions that improve product quality, process capability, safety, yield, cost performance, and cycle time. Partner with engineering, manufacturing, and operations teams to support sustaining activities and strategic manufacturing initiatives. Provide technical guidance on quality engineering principles, methods, and regulatory requirements to cross-functional stakeholders. Required Qualifications Bachelor's degree with 2+ years of relevant experience in quality engineering, manufacturing engineering, or a related technical role within a regulated manufacturing environment, OR Master's degree with 0+ years of relevant experience. Experience supporting quality engineering activities within a regulated manufacturing environment. Experience analyzing technical, manufacturing, or process data to support investigations, root cause analysis, and corrective actions. Experience creating, reviewing, or approving technical documentation supporting manufacturing processes or quality system requirements. Preferred Qualifications Experience reviewing and approving engineering, validation, or quality system documentation. Experience supporting process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Experience developing, executing, and analyzing Test Method Validations. Experience creating or supporting risk management and validation documentation, including Process Failure Mode and Effects Analysis (PFMEA) and Master Validation Reports. Knowledge of statistical and quality engineering tools, including Design of Experiments (DOE), Statistical Process Control (SPC), capability studies, and hypothesis testing. 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 to our employees lives a