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Mechanical Engineer labelling
Ref No.: 18-50871
Location: Franklin Lakes, New Jersey
Position Type:Direct Placement
Start Date: 07/19/2018

Mandatory Skills:

· Product Design / product sustenance experience
· 5+ years of work experience. The individual in this position will have a complete understanding of a wide application of technical principles, theories and concepts. He/She provides solutions that are imaginative, thorough and practical to a wide range of complex problems.
· Manufacturing process knowledge
· Knowledge on standards and regulatory requirements for various regions
· Technical (report) writing
· Device Labelling and use of Symbols
· Disposable device development
· Change control Management
· NC/CAPA Knowledge
· Design verification
· Process Validation
· DHF Preparation
· European Requirements (EU MDR)
· Risk Management Knowledge
· ISO 13485 / FDA Guidelines
· GD&T
· Prototyping
· Solid works
· Communication

Responsibilities:

· Independently determines and develops approach to solutions.
· Contributes to a project of considerable significance or leads smaller scope projects.
· Supports material/design/process changes to the product line through design control process, with well-documented research/analyses. Demonstrates accountability for successful and timely completion of designated tasks.
· Should be familiar about medical device standards and develop technical solutions to complex problems using sound engineering principles,
· Utilizing experimental, computational and analytical methods.
· Knowledge of Solid works CAD Tool is added advantage
· Applies innovative & logical risk based approach to product development challenges with the capacity for original thinking. Develops robust test methods, design test fixtures and execute measurement system analysis.
· Writes implements and leads bench studies, tolerance stack up analysis, design verification, validation, vendor interactions, materials specifications and component specifications.
· Performs data analysis using statistical tools, regression analyses and develop transfer functions.
· Collects, records, reports, interprets and analyzes data, presents results to peers and business leadership.
· Provides advanced engineering skills and product evaluation support to the platform toward building business cases for new opportunities.
· Should have good communication skill, Must have to regularly interact with client and Offshore team