Description

You will manage manufacturing processes and provide technical support within a medical device environment.

This role is on-site.

Responsibilities

• Execute process validation activities, including IQ/OQ/PQ protocols and test method validations.
• Qualify tooling, gages, and fixtures used in production.
• Validate controlled facilities, warehouses, and cleanroom environments.
• Apply statistical process control and DFMA principles to optimize product design and manufacturing.
• Interpret engineering drawings using GD&T to ensure manufacturing accuracy.

Required Skills

• 5+ years of manufacturing experience within the medical device industry.
• In-depth knowledge of FDA regulations, ISO 13485, and ISO 14644 standards.
• Proficiency in IQ/OQ/PQ protocols and process validation.
• Experience with process development, design, and Quality Function Deployment.
• Strong understanding of Statistical Process Control and applied statistics.
• Knowledge of product design, DFMA, and plastic/metallic material processing.
• Ability to interpret GD&T (Geometric Dimensioning and Tolerancing).
• Knowledge of biocompatibility requirements for medical devices.

Preferred Skills

• Experience with ergonomics, financial analysis, and project management.
• Knowledge of marketing and market research strategies.

Key Skills

Education

Any Graduate