Senior Manufacturing Engineer

Overview

Lead end-to-end manufacturing transfer, process qualification, supplier transfer and cost optimization projects for medical technology, working with global operating units, suppliers and cross-functional teams.

What you'll do

• 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.
• 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 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.
• 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.
• 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.
• 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.

What you'll need

• Bachelor's or master's degree in mechanical engineering, Production Engineering, or a related engineering discipline.
• 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.

Nice to have

• Exposure to 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.

Details

• Location: Nanakramguda, Hyderabad, India.
• Medtronic Incentive Plan (MIP) short-term incentive eligibility.