Production Engineer

A manufacturing engineer is responsible for reviewing and validating engineering drawings to ensure they are manufacturable, accurate, and complete. They apply their knowledge of medical device regulations to execute gap assessments, manufacturing print reviews, and remediation activities.

This role involves participating in ideation activities to assess project scoping and viability through economic analysis, conflict analysis, and supplier quote validation. The candidate will also be responsible for coordinating with suppliers to resolve technical queries and ensuring timely and high-quality project delivery.

• Review and validate engineering drawings for manufacturability, accuracy, and completeness as per the latest engineering standards.
• Apply knowledge of medical device regulations to execute gap assessments, manufacturing print reviews, and remediation activities.
• Participate in ideation activities to assess project scoping and viability through economic analysis, conflict analysis, and supplier quote validation.
• Conduct, review, and update models for tol-stackup studies and dimensional variation analysis (1D/2D) using Creo-CETol or other tools.
• Apply project management skills to plan, schedule, and monitor project activities efficiently ensuring FTR & OTD excellence.
• Collaborate with global stakeholders across regions like category managers, sourcing, PM, and other cross-functional teams as per the project needs.
• Review and validate PPAP reports received from suppliers and assess if the technical specifications are met.
• Well-versed with engineering change management procedures using PDM/PLM software (Agile, Windchill, etc.).
• DFMEA/PFMEA and design reviews to assess and mitigate design & Mfg risks.
• Develop and refine detailed 2D drawings and 3D CAD models to support project requirements.
• Design remediation (engineering specification gap assessment).
• Assist in developing master validation plans, including process flow, OQ, and PQ.
• Perform CPK (process capability index) and ANOVA (analysis of variance) studies.
• Conduct criticality analysis to ensure process reliability and quality.

• Bachelor's degree in mechanical/production engineering with min 9–12 years of relevant experience.
• Strong expertise in DFM&A principles and manufacturing methods for plastics, metals, and packaging components & Systems.
• Proven experience in analyzing project feasibility for cost savings and efficiency improvements.
• Proficiency in CAD - Creo/SW and PLM/PDM tools (preferably Windchill).
• Solid understanding of project management methodologies, including planning, tracking, and cross-functional collaboration.
• Strong verbal & presentation skills for effective collaboration with global teams.
• Well-versed with MS PowerPoint, Excel for reports preparation, data analysis/advance operations.
• Proficient in conducting Production Part Approval Process (PPAP) to ensure compliance with technical specifications and quality standards.
• Skilled in performing detailed Root Cause Analysis to identify issues, implement corrective actions, and drive continuous improvement.

• Should costing experience with metals and plastic commodities.
• Experience working with electronic components and their design specifications.
• Familiarity with Six Sigma methodologies (DFSS/DMAIC) for data analysis, root cause identification, and process design/improvements.
• Hands-on experience in reverse engineering components to recreate CAD models and extract design intent using advanced inspection techniques (e.g., 3D scanning, measurement tools).
• Knowledge of Lean Manufacturing principles to eliminate waste, improve process flow, and enhance operational efficiency.
• Minitab, Statistical analysis.
• VAVE experience for cost down project execution and certification (SAVE/INVEST).
• GD&T Certification.
• PMP trained/Certified.