Engineering Co-op - Quality Assurance - Product Surveillance

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 student pursuing an engineering degree to support the Product Surveillance team in Naples, FL.  The Product Surveillance team is responsible for the intake, documentation, investigation, reporting, and trending of product quality complaints to support product safety, quality, and regulatory compliance.  With the support of fellow team members, the successful candidate will assist with the intake, documentation, evaluation, investigation, and trending of product quality complaints. Responsibilities include performing complaint investigations, conducting data analysis and trending activities, preparing technical reports, and supporting engineering projects related to product performance and quality. The ideal candidate will demonstrate strong attention to detail, organizational skills, and the ability to accurately document findings while working within established procedures and regulatory requirements. The individual will be expected to manage assigned tasks effectively, communicate findings and issues in a timely manner, and contribute to the continuous improvement of complaint handling and product surveillance processes.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This co-op will run from January 2027 – June 2027.  The ideal candidate will have the availability to work 40 hours per week at our Naples, FL facility.

Main Objective:

To support the Product Surveillance team with medical device complaint handling, investigation, and data analysis.

Essential Duties and Responsibilities:

• Receive and analyze previous complaint data and leverage for future investigations.
• Assist with data gathering and analytics for monthly complaint trending activities.
• Perform root cause analysis for returned complaint devices or identified trends as appropriate. 
• Support global complaint triage, intake, evaluation, reporting, investigation, closure and trending activities. 
• Partner with design, manufacturing and quality engineers as well as product management teams to drive continuous process and product improvement.
• Review of Supplier Quality Agreements and incorporation of information into electronic complaint system.
• Other duties as assigned.

Education and Experience:

• Enrolled as a full-time student pursuing a bachelor's degree in engineering or engineering technology, or a recent engineering or engineering technology graduate, required.  Junior or above, studying Mechanical or Biomedical Engineering preferred.
  (Recent graduates must be within six months of their graduation date to qualify.)

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Ability to effectively communicate, oral and written, and possess the ability to work through technical issues.
• Knowledge of Regulatory and ISO guidelines pertaining to medical devices preferred.
• Basic knowledge of product risk management, CAPA, and Nonconformance Reporting (NCR) preferred.
• Knowledge of orthopedic medical devices (implant, instruments, biologics, etc) preferred.

Machine, Tools, and/or Equipment Skills:

PC; Familiarity with Microsoft Office Suite preferred.