Lead Manufacturing Engineer

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 a Lead Manufacturing Engineer, you will collaborate closely with global operating units, suppliers, sourcing, quality, regulatory, and engineering teams to ensure timely and successful completion of assigned programs. This role will focus on medium- to high-complexity manufacturing transfers, supplier transfer programs, vertical integration, cost optimization, process qualification, PPAP execution, and manufacturing readiness. You will help strengthen supply reliability, improve cost competitiveness, and support the delivery of high-quality medical technology for patients around the world. You will be expected to lead technical discussions, resolve manufacturing challenges, apply data-driven engineering judgment, and model the Medtronic Mindset by acting boldly, moving with speed and decisiveness, fostering belonging, and delivering results the right way. Responsibilities may include the following and other duties may be assigned: Lead end-to-end execution of manufacturing transfer, qualification, and optimization projects from scoping through implementation.Plan, schedule, track, and report project progress against quality, cost, and timeline commitments.Collaborate with global operating units, suppliers, sourcing, quality, regulatory, and engineering stakeholders to ensure timely project execution.Identify risks, challenges, and constraints early and drive mitigation plans with cross-functional teams.Facilitate supplier and cross-functional reviews to support alignment, decision-making, and project governance.Manufacturing Engineering and Supplier SupportProvide technical support to suppliers by interpreting product drawings, reviewing manufacturing drawings, and resolving production-related technical issues.Review and validate engineering drawings for manufacturability, accuracy, completeness, and alignment with applicable engineering standards.Support manufacturing process development for injection molding, stamping, pressure die casting, cleanroom manufacturing, and related regulated manufacturing environments.Drive the process improvement opportunities to strengthen manufacturing robustness, accelerate milestones, and improve decision-making.Review and validate PPAP deliverables to confirm compliance with technical specifications and quality expectations.Process Qualification and ValidationLead or support process qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Develop, review, and approve Master Validation Plans, process flows, validation protocols, and related qualification documentation.Apply medical device manufacturing standards, Good Manufacturing Practices (GMP), 21 CFR Part 11 expectations, and quality management requirements.Ensure validation documentation and supporting artifacts are complete, compliant, and ready for stage-gate approvals.Statistical Analysis and Measurement SystemsUse Minitab and statistical tools to perform process capability studies, including Cpk and related process performance analysis.Conduct ANOVA, regression, criticality analysis, and data-driven studies to improve process reliability and quality.Perform Measurement System Analysis, including GR&R studies, and identify appropriate MSA methods for process and inspection needs.Use statistical evidence to support validation conclusions, supplier readiness, and manufacturing decision-making.Risk Management and ComplianceEngineering Change ManagementPartner with Quality during risk management activities and actively participate in design and process reviews, including DFMEA and PFMEA.Identify risks impacting cost, quality, manufacturability, compliance, and schedule, and drive mitigation actions with suppliers and cross-functional teams.Support engineering change management activities using PLM/PDM systems such as Agile and Windchill.Maintain required compliance documentation and ensure technical artifacts support stage-gate reviews, change approvals, and quality requirements. Required Knowledge and Experience: Bachelors or masters degree in mechanical engineering, Production Engineering, or a related engineering discipline with 10 to 14 years of relevant experience in manufacturing engineering, supplier transfers, process validation, product sustenance, or regulated manufacturing environments.Strong understanding of medical device manufacturing standards, GMP, 21 CFR Part 11 expectations, validation practices, and quality management .