Description

Own validation protocols, process development, and regulatory compliance for medical device manufacturing.

Responsibilities

• Write and execute validation protocols (IQ, OQ, PQ) and associated reports.
• Develop manufacturing processes, specifications, and operator instructions.
• Conduct investigations, root cause analysis, and problem-solving activities.
• Update PLM systems with procedures, bills, routes, and travelers for product changes.
• Collaborate with multi-functional teams and OEMs on asset commissioning and validation strategy.

Required Skills

• 6+ years of experience in manufacturing engineering.
• Expertise in medical device regulations and FDA compliance.
• Hands-on experience with validation (IQ/OQ/PQ).
• Proficiency in PLM systems for managing specifications and routes.
• Strong knowledge of root cause analysis and problem-solving methodologies.
• Ability to work with cross-functional teams (Operations, Quality, Engineering).
• Proficiency in Microsoft Office.

Preferred Skills

• Experience with EIS (Enterprise Information Systems).

Key Skills

Education

Bachelor's degree