Engineering, Product Surveillance

Essential Duties and Responsibilities

• Develop and promote the Arthrex Product Surveillance processes for medical devices, including developing, managing and maintaining global policies and procedures.
• Perform root cause analysis for returned complaint devices or identified trends as appropriate.
• Maintain test protocols to evaluate returned product according to established specifications and record detailed results.
• Perform device evaluations when needed.
• Partner with Design Engineering, Manufacturing Engineering, Product Management, and Quality Engineering teams to drive continuous process and product improvement.
• Function as the global representative for complaint investigation, escalation, and trending processes during Agency/3rd Party Audits and assists in the preparation and submission of audit responses and requests for information to FDA, Notified Body and other Regulatory Bodies.
• Provide timely customer feedback to key stakeholders through root cause analysis, statistical analysis and regularly scheduled forums.
• Support global complaint triage, intake, evaluation, reporting, investigation, closure and trending activities.
• Manage supplier relationships from initial notification to receipt of a supplier complaint evaluation.

Education and Experience

• Engineer II - Bachelor's Degree in Engineering required and 2 years engineering experience in a regulated environment required.
• Previous experience with Project Management, root cause analysis, and continuous improvement required.
• Engineer Sr - Bachelor's Degree in Engineering required and 5 years engineering experience in a regulated environment required.
• Previous experience with complaint investigation, statistical analysis, project management, root cause analysis and continuous improvement required.

Machine, Tools, and/or Equipment Skills

Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company). SAP and/or SmartSolve Quality Data experience desirable.

Reasoning Ability

Ability to identify opportunities, collect data, analyze established facts, draw valid conclusions, and implement change. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.