2018-06-05

Manufacturing Engineer
Job Opportunity at Professional Partners Group

Posted on Jun 5

http://www.professionalpartnersgroup.net    (623) 755-0184

Location: Mesa, AZ
Job Type: Contract
Job ID: W4161101

Job purpose statement
The Manufacturing Engineer is a manufacturing and process development expert leading project work related to manufacturing integration of medical devices.This individual will be involved in all phases of product development as a key contributor representing manufacturing. You will work with R&D to ensure designs are manufacturable, evaluate potential suppliers, and work with internal and external teams to develop and validate manufacturing processes.

 
           
Essential duties and responsibilities
No. Major duties Description
1. Process development and validation Drive efforts to design, develop, validate, and continuously improve manufacturing processes.
2.   Develop & define production control methods to monitor process output and establish critical supplier metrics.
3.   Define and coordinate the design and development of manufacturing fixturing and test equipment.
4.   Coordinate with R&D at suitable stages to optimize the design for manufacturing and reliability.
5.   Perform or direct DOE, correlation studies and apply statistical analysis for product and process improvements. 
6.   Lead and support manufacturing development and transfers to contract manufacturers.
7. Design Controls documentation Provide input to the User Requirements and System Requirements Documents.
8.   Ensure compliance to the requirements of ISO13485 standards, FDA regulations and Good Manufacturing Practice regarding process, design and development of new and existing products. 
9. Supplier evaluation and selection Identify potential suppliers and perform technical evaluation for selection.
10. Develop the team Guide work and mentor junior team members
11. Other duties as assigned  
           
           
Job related qualifications/skills
        Please select
        preferred / required
Education
Bachelor’s Degree in ME or EE or other relevant Engineering discipline Required
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Professional experience
3-7 years of related design and manufacturing experience in the medical device and/or component industry Required
Design Control experience including design and process verification and validation Required
Injection molding, die casting, tooling experience Preferred
Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ and PPQ) Required
 
Knowledge, skills and abilities (incl. languages)
Thorough understanding of test method validation, GR&R, GD&T, and statistical analysis Required
Solidworks or other CAD experience Preferred
Familiar with project management methods and tools Preferred
 

Knowledge of methods
Practical knowledge of Six Sigma methodologies. Green or Black Belt certification preferred Preferred
Understanding and application of ISO Quality System requirements and FDA regulations Required
Familiar with a variety of manufacturing processes including mechanical and electromechanical Required
 
Personal skills
Ability to work effectively with internal and external teams Required
Demonstrated ability to deliver results with minimal supervision Required
Ability to support and direct the efforts of junior level engineering staff Required
 
 
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