Quality Engineer Role at Medtronic

Core Responsibilities

The role involves designing automated inspection and testing methods for medical devices, coordinating with vendors, and ensuring all manufacturing processes comply with international regulatory standards like 21 CFR Part 820, ISO 13485, and EU MDR.

Technical Expertise and Quality Management

The engineer is expected to perform Risk Assessments and PFMEA, manage the systems development life cycle, and support AI/ML integration. Proficiency in process improvement methodologies such as Lean Six Sigma, DMAIC, and Root Cause Analysis is required to manage CAPA and non-conformance.

Validation and Statistical Methods

Responsibilities include leading V&V efforts, specifically FAT, SAT, IQ, OQ, and PQ. The role demands strong statistical skills, including DOE, ANOVA, SPC, and Gage R&R, to ensure robust process capability and test method validation.

Logistical Requirements

This position is based in North Haven, CT, requiring an onsite presence four days per week and 25% domestic travel for vendor system acceptance testing.