Validation Engineer II

Arthrex

10d•Onsite

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Validation Engineer II for our Pendleton, SC manufacturing location. Successful candidates must possess a Bachelor’s degree in Engineering or Engineering Technology with at least 2 years of relevant experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™. Main Objective: Responsible for supporting the AMI Validation Manager with all process validation related support for the life cycle development and manufacturing of Class I, II and III medical devices.

Requirements

Bachelor’s degree required preferably in an Engineering or Engineering Technology discipline.
2 years of Process Validation work experience required, preferably within a Medical Device Company.
Knowledge of testing equipment, statistical methods, control plans.
Knowledge of cGMP and GDP requirements.
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP or similar inventory software and MiniTab.

Responsibilities

Responsible for writing of protocols and conducting validations of special processes, including cleaning and passivation, electropolishing, molding, etc.
Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities
Other duties as assigned