R&D Engineer

Role: R&D Engineer Client: LTTS/Beckton Dickinson Location: Franklin Lakes, NJ(Onsite) Job Description & Skill Requirement: 1. Understanding of Packaging requirements, Requirement Analysis, Review Feasibility for - Medical Device - Sterilized Packaging - Non Sterile Component Packaging 2. Work with Vendors for Packaging components - Provide packaging Specifications to the Vendors - Review and approve packaging design provided by Vendors - Coordinate Prototype Development 3. 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 4. 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 5. Knowledge of Standards - Design Controls - ISO 13485, FDA CFR Part 820 - Awareness of ISO11607, ASTM D4169 6. 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: • Graduation Skills: • Understanding of Sterilized Packaging requirements for Medical devices

Created: 2024-10-19