Engineer Tech - Packaging Lean Operations- Ave Maria, FL.

 Requisition ID:                       61603                          Title: Engineer Tech - Packaging Lean Operations- Ave Maria, FL. Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL. 

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing, Ave Maria, FL. Location is actively searching for a Packaging Lean Operations Engineer Technician to provide technical support to AMI Packaging Engineering, Packaging Operations, Manufacturing Engineering, and INC Packaging and Design Engineering.  To support projects involving: commercialization of new products; improvements in product and process performance; increases in productivity; and reduction of costs. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Hours - Monday-Friday, 8:00 am – 5:00 pm

 

Essential Duties and Responsibilities:

• Supports new product development by assisting with Packaging Design validations and Process/Equipment validations in the Laser, Passivation, Cleaning, Assembly, Packaging, Boxing, and 2nd Pack areas. 
• Develops sampling and testing plans under the direction of the area process/manufacturing engineers to support Engineering Studies and Validation protocols.
• Supports department Process Engineers in drafting and executing validation protocols and reports (DOE/IQ/OQ/PQ) for the following processes: laser-marking, passivation, cleaning, manual and automated assembly, pouch sealing, blister sealing, and automated assembly processes.
• Supports department Process Engineers in drafting work instructions.
• Supports department Process Engineers with designing, procuring, assembling new tools and fixtures used in production. 
• Ensures tool and fixture drawing documentation is created/revised according to governing procedures.
• Supports the design and maintenance of tools and fixtures:  Supports Production in the control, repair tracking, and inventory of tools and fixtures.  Requests quotes as needed for new tool/fixtures and/or for repairs.
• Supports the Calibration department by identifying and locating process equipment and test instruments that require calibration.
• Supports the Product engineers during new product and/or packaging introductions into the Packaging Department (Laser, Passivation, Cleaning, Clean Rooms, Boxing, 2nd Pack).
• Maintains precise identification and control of validation samples and ensures information and documentation is consistently accurate. 
• Remains current with ISO/FDA/STM standards and internal quality assurance policies.
• Performs production equipment setups and troubleshooting where required.
• Verifies and documents machine settings and test results where required.
• Performs time studies and collects data to support continuous improvement activities.

 

Education/Experience:

• High School Diploma or equivalent required.
• 2 years Manufacturing experience or other technical professional work (ASE, HVAC) required.
• Ability to understand Drawings, Blueprints, BOM’s, Routings, Validation Protocols, and DHR’s preferred.
• Lean Manufacturing experience is preferred.
• Experience with computerized ERP and PLM systems (Oracle, SAP, Agile, etc.) preferred.

 

Skills

• Basic knowledge of MS Office programs required.
• Basic ability to navigate SAP, Documentum, and Agile required.
• Basic ability to understand engineering specifications and drawing conventions.
• Basic knowledge of component manufacturing, product assembly, visual inspection, packaging processes, and labeling requirements.
• Knowledge of raw materials, inventory