Product Engineer 2

Title: Product Engineer 2
Location: Flanders, NJ
Duration: 12 Months


Supports the manufacturing organization with process creation and maintenance. Works to identify root cause while troubleshooting electro-mechanical medical devices. Provides support in review of results to determine that products perform in the intended manner. Provides support in documenting product issues for future reference and problem resolution. Drives projects to increase productivity and reduce product cost.
Evaluates designs and proposes revisions to improve manufacturability.
Implement design changes into production by coordinating activities between cross-function teams in manufacturing and write reports.
Evaluate non-conforming materials and provide guidance on disposition.
Write / execute process validation and verification protocols. Write reports.
Create / update manufacturing assembly and test procedures.
Investigate CAPAs
Work with external suppliers on part issues and process improvement projects
Identify manufacturing issues (design/process/component) and drive resolution by participating on cross-functional or project teams.
Research and resolve electro-mechanical, production assembly and/or test issues in a timely manner.
Define critical processes, develop assembly and test procedures, train production personnel, and verify effectiveness of process and training
Design, develop and validate test fixtures to be used in-house and at vendor sites
Supports cross functional teams in a collaborative environment

Required Knowledge/Skills, Education, and Experience
BS Engineering required 
FDA/ISO/Med Device 
3+ years experience 
Qualified Applicants must be legally authorized for employment in the United States. Qualified Applicants will not require employer sponsored work authorization now or in the future for employment in the United States. 
 Preferred Knowledge/Skills, Education, and Experience 
 Experience with process FMEA 
 Lean Manufacturing 

Thank you,
Sachin Patil,

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