Mechanical Design Engineer in Milpitas, CA; Onsite- Locals; Semiconductor domain

Overview

Packaging Validation Engineer (Medical Devices) —
Location:
Bloomington, IN (Onsite). JD includes IQ/OQ/PQ and packaging validation of medical devices.

Mandatory: Medical Device Industry

• Recent 4-6 years’ experience in Packaging Validation activities
• Hands on experience in packaging validation activities, including packaging integrity, shelf life, and transit testing
• Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements
• Hands-on experience in Process validation (IQ, OQ & PQ) activities
• Lead or support complaint investigations and resolution related to packaging
• Support engineering in product validation, risk assessments, product/process development, and change management
• Support and lead continuous improvement activities through leadership, facilitation, and collaboration
• Ensure all packaging validation activities are properly documented and controlled
• Collaborate with QA, Engineering, Manufacturing, and Regulatory teams to ensure packaging meets product and compliance requirements
• Communicate effectively across departments regarding packaging validation status and issues
• And generally align packaging validation activities with the Quality Engineering/QA Manager and manufacturing, production engineering, and supply chain teams
• Good documentation practice skills
• Good verbal and written communication skills
• Good knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820
• Hands on experience in Engineering change order creation in Agile

• Mid-Senior level

• Contract

• Information Technology

• IT Services and IT Consulting