R&D Engineer (Packaging)

Job Description & Skill Requirement Understanding of Packaging requirements, Requirement Analysis, Review Feasibility for:

• Medical Device - Sterilized Packaging
• Non Sterile Component Packaging

Work With Vendors For Packaging Components

• Provide packaging Specifications to the Vendors
• Review and approve packaging design provided by Vendors
• Coordinate Prototype Development

Analysis Of Engineering Work Orders

• Familiarity in System Engineering practices and principles for medical devices
• Experience with combination device development
• Differences in Drawing/Document Revisions and its impact
• Engineering Documentation
• Design Input and Outputs
• Knowledge of CAD Tools - Solid Works

Work On Design Verification Activities

• Design Verification Plan and Report
• Test Strategies
• Test Methods
• DHF Management
• Basic knowledge of Statistics, Sampling Plan
• Experience with Minitab for data analysis

Knowledge Of Standards

• Design Controls – ISO 13485, FDA CFR Part 820
• Awareness of ISO11607, ASTM D4169

Other Skills

• Stake holder management and ability to work within the Cross Functional Team
• Thorough and Detail oriented
• Excellent Communication - Verbal and Written
• Ability to prioritize

Qualification: Bachelor Degree in Packaging / Industrial Engineering, or other engineering discipline