Source description
About the role
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
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