Engineer II, Product Surveillance

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Requisition : 67600 Title: Engineer II, Product Surveillance

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively searching for an Engineer II, Product Surveillance for our global headquarters in Naples, FL who is responsible for driving product improvement through performing and supporting Product Quality Complaint evaluations and investigations. The Engineer II will also analyze data trends and provide timely feedback to key stakeholders.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

• 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.

• BS Degree in Engineering
• 2 years engineering experience in a regulated environment required.
• Knowledgeable of Regulatory and ISO guidelines for the development of medical devices required
• Knowledgeable of medical device complaint handling and adverse event reporting requirements preferred.
• Knowledgeable of product risk management, CAPA, and Nonconformance Reporting preferred

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 Smart Solve Quality Data experience desirable.

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.

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

Ability to comprehend and apply language skills to the degree required to perform the job based upon the…