Sr Quality Engineer

Job description

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 LifeEducation: Bachelor’s degree in engineering required. Experience: Minimum of 4 years of relevant engineering, quality, or manufacturing experience required; or a master’s degree in engineering with a minimum of 2 years of relevant experience. Regulated manufacturing: Experience working in a regulated manufacturing environment, preferably medical devices, pharmaceutical, or other highly controlled industry. Quality Systems: Working knowledge of quality system expectations, including documentation, nonconformance handling, corrective and preventive actions, change control, and audit readiness. Technical execution: Ability to support manufacturing process quality activities, investigations, validation deliverables, risk assessments, and product/process performance monitoring. Nice to Have: Education discipline: Preferred bachelor’s or master’s degree in Mechanical, Industrial, Electrical engineering. Medical device experience: Experience in medical device or other FDA/ISO-regulated manufacturing environment, including GMP expectations and inspection readiness. Quality systems: Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. Validation: Knowledge of equipment, process, product, and software validation concepts, including URS, SRS, IQ, OQ, PQ, risk-based validation, and implementation readiness. NPI, Transfer, and Supplier Quality: Experience supporting New Product Introduction (NPI), product transfers, supplier qualification, supplier performance monitoring, component qualification, and supplier quality improvement initiatives in a regulated manufacturing environment. Manufacturing process knowledge: Experience supporting machining, anodizing, final pack, inspection, test methods, component qualification, or other manufacturing process controls. Problem solving and risk: Experience applying root cause analysis and risk assessment tools such as 5 Whys, Fishbone, FMEA, fault tree analysis, or similar structured methods. Data and statistics: Experience using SPC, capability analysis, DOE, trending, sampling rationale, or statistical methods to support investigations, process monitoring, and continuous improvement. Digital tools: Hands-on experience with Minitab, JMP, Excel advanced functions, Power BI, PowerPoint, SAP, JDE, Factory Works, or similar systems used for data analysis, reporting, traceability, and manufacturing execution. Continuous improvement: Lean Six Sigma Green Belt, Black Belt, or equivalent training/certification preferred. Technical writing: Demonstrated ability to write clear, technically sound, and audit-ready protocols, reports, investigations, justifications, and quality documentation. Leadership and collaboration: Strong critical thinking, communication, prioritization, and cross-functional collaboration skills in a fast-paced manufacturing environment. Automation and AI enablement: Experience with data extraction, automation, dashboards, or basic programming tools such as VBA, Python, Copilot, ChatGPT, Gemini, or similar applications to improve reporting and process analysis. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills. DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product. Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.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 Medtron