Repair Technician II - Medical Devices

Arthrex

2d•$23 - $40•Onsite

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Repair Technician II will support the Repair department in the assembly, testing, repairing and evaluation of medical devices, components, and manufacturing processes to produce cost effective quality products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

Intermediate knowledge of product lines applicable to GSR repair lines.
Microsoft Office knowledge required (Office, Word, Outlook).
Ability to write and record data and information as required by procedures.
High school diploma equivalent required.
Experience working in an FDA regulated environment required.
Experience working in a fast paced, multilayered work environment required.

Nice To Haves

Knowledge of FDA and ISO regulations preferred.
SAP and Quest (Complaints database) experience preferred
3 Years’ experience in the medical device industry or similar preferred.

Responsibilities

Directly responsible for supporting repair operations in the daily product testing by performing FCO (Final Checkout), FCL (Final Check Out) and automated or manual electrical tests.
Capable of testing electronic components, sub-assemblies, and video systems following documented procedures.
Test’s products using computer programs, Digital Multi Meters, Oscilloscopes, light measurement equipment, waveform monitoring equipment, digital and analog electrical test equipment.
Record test results into database applications. Review numerical and graphical data and make recommendations to improve process yields.
Records test procedures and results, numerical and graphical data per Good Manufacturing Practice guidelines.
Records test failures and document for repair or component replacement.
Operates a variety of hand-operated tools and electronic equipment to repair product specified on work orders using standard work instructions and inspection procedures.
Receives returned products into ERP system, determine appropriate action and handling.
Prepares, issues, and kits materials based upon the Repair Work Order Pick List requirements according to work instructions and departmental guidelines
Manages tasks related to multiple repair processes, prioritize, and respond to special assigned duties.
Performs inspection of work completed and documentation to assure correct specifications and functional criteria have been met.
Performs area clearance by clearing and cleaning in work area to maintain material traceability.
Candidate must be able to work with minimal supervision.
Manage tasks related to multiple production duties; prioritize and respond to special assigned duties.
Completes complex tasks and assignments in creative and effective ways.
Determines root cause analysis using a variety of factors including data analysis.
Makes recommendations for new procedures and implements approved recommendations.
Participates in product, process, and company training activities in support of medical device manufacturing.
Performs or initiates any cleaning in work area or maintenance required by the Preventive Maintenance schedule on the machines within the department.
Support department with internal/external audits, NCR’s and or CAPA’s.