Manufacturing Engineer II

About this role

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Skills you'll use

What you'll do

• Prepare, review, revise, and maintain controlled Manufacturing Engineering documentation throughout the product lifecycle.
• Manage document control activities, including document creation, review, approval, release, revision, and archival within PLM, ERP, and Document Management Systems.
• Support Engineering Change Management (ECR/ECO/ECN/MCO) by preparing and implementing engineering change documentation.
• Maintain product configuration, manufacturing master data, and product attributes to ensure data accuracy and integrity.
• Prepare, review, revise, and maintain process risk management activities by maintaining PFMEA and other manufacturing risk assessment documentation.
• Ensure engineering documentation complies with QMS, Good Documentation Practices (GDP), ISO 13485, FDA/QMSR, MDR, and internal quality requirements.
• Collaborate with Manufacturing Engineering, Quality, Operations, Design Engineering, Regulatory Affairs, Supply Chain, and Facilities to support engineering deliverables.
• Coordinate cross-functional document reviews, approvals, and documentation status to ensure timely project execution.
• Support New Product Introduction (NPI), manufacturing transfer, process improvement, validation, and sustaining engineering projects.
• Prepare or review necessary validation plans, protocols, and procedures for successful completion of transfer activities. (IQ, OQ, PQ, MVP/MVR, SPC control, GRR).

Who can apply

• Bachelor’s degree in mechanical OR production engineering OR equivalent with 6 to 8 years of experience in manufacturing and operations.
• Experience with risk management, including but not limited to Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk management tools.
• Prepare, review, revise, and maintain controlled Manufacturing Engineering documentation throughout the product lifecycle, (CP, Process sheets).
• Product Lifecycle Maintenance and Product Labeling Updates.
• Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
• Knowledge on GD&T & experience in interpreting mechanical drawings.
• Working understanding statistics, including sample size selection, data distribution analysis, capability calculations, Design of Experiments (DOE), and Analysis of Variation.
• Strong Knowledge in Lean Manufacturing / Six Sigma methodologies including Value Stream Mapping, Line Balancing, FTQ, 8Wastes, 5S etc.
• High degree of understanding/knowledge of Machining, Molding, Grinding, Forming, Assembly, Welding, Finishing, Cleaning, Passivating, Anodizing, Shot Peening, Mass Media Operations, Coatings, EDM, Casting, Forging, Polishing.
• Good understanding on inspection methods and procedures. (Test Method validation TMV).

Perks & benefits

About Medtronic

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