Quality Engineering Role in Medtronic Automated Manufacturing

Core Responsibilities

The role involves designing automated inspection and testing methods for medical device manufacturing, managing vendor relationships, and ensuring that components and finished products adhere to stringent internal and external regulatory requirements.

Regulatory Compliance and Risk Management

Engineers must navigate complex frameworks including 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and GAMP 5. Key tasks include conducting Risk Assessments and Process Failure Modes and Effect Analysis (PFMEA) to maintain quality standards.

Process Improvement and Technical Validation

The position utilizes Lean Six Sigma, DMAIC, and Root Cause Analysis for continuous improvement. Technical expertise is required in Verification & Validation (V&V) processes, including FAT, SAT, IQ, OQ, and PQ, alongside statistical methods like ANOVA, Gage R&R, and SPC.

Innovation and Future-Proofing

A significant focus is placed on the systems development life cycle, integrating AI/ML technologies into manufacturing and inspection processes to optimize performance and ensure compliance with evolving industry standards.