Engineer Tech, 3rd Shift - (Packaging)- Ave Maria, FL.
ArthrexAbout the role
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Packaging Engineer Tech would 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™, located at our Ave Maria, FL manufacturing site.
Third Shift- Monday - Friday - 10:30PM- 7:00AM
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.
- 3 years Manufacturing experience or other technical professional work (ASE, HVAC) required.
- Ability to understand Drawings, Blueprints, BOM’s, Routings, Validation Protocols, and DHR’s required.
- Lean Manufacturing experience is preferred.
- Experience with computerized ERP and PLM systems (Oracle, SAP, Agile, etc.) preferred.
- Experience with Microsoft Office and CAD products required.
Skills:
- Knowledge of MS Office programs required.
- Basic ability to navigate SAP, Documentum, and Agile required.
- Ability to open and view drawing specifications.
- Knowledge of administrative procedures and computer systems such as managing files and records.
- Ab
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