Lead Manufacturing 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 LifeAs 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 Support Provide 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 Validation Lead 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 Systems Use 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 Compliance Engineering Change Management Partner 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: Bachelor’s or master’s 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 systems. Knowledge of manufacturing processes such as injection molding, stamping, pressure die casting, and cleanroom manufacturing setups. Strong knowledge of DFMEA, PFMEA, risk management, root cause analysis, and corrective action practices. Working knowledge of CAD tools such as SolidWorks or Creo and PLM/PDM systems such as Agile or Windchill. DMAIC Or Lean Six Sigma Green Belt or Black Belt certification or demonstrated experience applying Lean Six Sigma methods. Strong project planning, organization, communication, presentation, stakeholder management, influence management, and conflict resolution skills. Experience in supplier transfer, vertical integration, localization, cost optimization, or value engineering programs. Exposure should-costing, DFMA, aPriori, VAVE, SAVE/INVEST, or similar cost excellence methodologies. Exposure to GD&T, tolerance stack-up and reverse engineering methods. PMP training or certification or demonstrated experience managing cross-functional engineering projects. Knowledge of Power BI, data analytics, Python, or automation tools for reporting, process tracking, and decision support. 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. ‌ 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).