Senior Engineering Tech- (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. Arthrex Manufacturing is currently seeking a Senior Packaging Engineer Tech 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™.
If hired for this position, you will be eligible for a $750.00 sign-on bonus (minus appropriate tax withholdings) which will be paid in your first pay period.
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. A 2 year Associates Degree in a Math, Science, Technical or Engineering discipline preferred.
- Minimum of 5 Yrs. experience as an Engineering Technician or 5 years Manufacturing experience related to medical device manufacturing required or combination of college and direct experience required.
- Understanding of Drawings, Blueprints, BOM’s, Routings, Basic Statistics, Validations, and DHR’s required.
- Lean Manufacturing experience is strongly preferred.
- Experience with tool management and inventory systems required (Guhring, Matrix, etc.) required.
- Experience with computerized ERP and PLM systems preferred (Oracle, SAP, Agile, etc.) required.
- Expertise with Microsoft Office and CAD products required.
Knowledge:
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