Manufacturing Transfer Project Engineer (Medical Device) - iMPact Business Group

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Manufacturing Transfer Project Engineer for a 11 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

This position will support medical devices that are being transferred from the Lakeland, Florida manufacturing plant to the Chandler, Arizona and Tijuana, Mexico manufacturing plants. The position will support the product design, not the manufacturing processes themselves. The primary job activity will be researching product validation Design History File information to ensure that the new manufacturing lines meet all requirements to produce devices that remain concurrent with their original validation.

Responsibilities:

• The Project Engineer works within a cross functional team to execute various tasks within the manufacturing transfer process per associated timelines, quality requirements and budget.
• Works with current suppliers to understand how components and sub-assemblies are manufactured, review validation documents, conduct Supplier Quality evaluations in order to plan the transfer of manufacturing process to our clients manufacturing sites or other new suppliers/contract manufacturers. 
• Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations.
• Provide feedback and redlines on manufacturing work instructions, layouts, and equipment.
• Provides on-going status reports including periodic reviews progress and evaluation of results to management.
• Work closely with other functional areas of the company to drive successful project implementation.
• Some trave to either Arizona or Mexico could be required.

Preferred Qualifications: 

• Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment. 
• Strong communication skills with the ability to effectively work cross-functionally and externally as required. 
• Knowledge of manufacturing processes, materials, product and process design. 
• Experience in an FDA regulated environment (preferably Medical Device) or regulated industry beneficial. 
• Experience with managing Manufacturing transfer projects very beneficial
• Skilled with medical product validation and medical design history file familiarity 
• Experience in ECR/ECN and systems such as onePLM, Windchill & SAP beneficial 
• High level of PC Skills required. (MS Excel, Access, PowerPoint, MS Project). 
• Preferred Experiences: 
• B.S in Mechanical/Industrial/Electrical Engineering or related engineering discipline with minimum 5 years' work experience.

Preferred Qualifications: 

• Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment. 
• Strong communication skills with the ability to effectively work cross-functionally and externally as required. 
• Knowledge of manufacturing processes, materials, product and process design. 
• Experience in an FDA regulated environment (preferably Medical Device) or regulated industry beneficial. 
• Experience with managing Manufacturing transfer projects very beneficial
• Skilled with medical product validation and medical design history file familiarity 
• Experience in ECR/ECN and systems such as onePLM, Windchill & SAP beneficial 
• High level of PC Skills required. (MS Excel, Access, PowerPoint, MS Project). 
• Preferred Experiences: 
• B.S in Mechanical/Industrial/Electrical Engineering or related engineering discipline with minimum 5 years' work experience.