Engineering Co-op - Quality Assurance - Product Surveillance

Arthrex; Naples (FL); On-site; USD 25,000 - 36,000; Full time

Benefits offered by this job

Medical Insurance (if 25+ hrs/week)

Employee Assistance Program (EAP)

Free Onsite Medical Clinics

Free Onsite Lunch

Volunteer PTO (8 hours)

Job summary

Arthrex, Inc. in Naples, FL, is seeking a motivated engineering student for a quality assurance product surveillance co-op.

You will assist with intake, documentation, investigations and trending of medical device complaints under established procedures and regulatory requirements. The internship runs January 2027 through June 2027, requires 40 hours per week on site, and offers exposure to cross-functional teams in design, manufacturing and product management within a global medical device

Qualifications

• Enrolled as a full-time student pursuing a bachelor's degree in engineering or engineering technology, or a recent graduate; Mechanical or Biomedical preferred.
• Knowledge of Regulatory and ISO guidelines pertaining to medical devices is preferred.
• Basic knowledge of product risk management, CAPA, and Nonconformance Reporting (NCR) is preferred.
• Knowledge of orthopedic medical devices (implant, instruments, biologics, etc) preferred.

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.

Skills

Communication

Regulatory knowledge

Risk management

Orthopedic devices knowledge

Education

Bachelor's degree in engineering or engineering technology

Tools

Microsoft Office Suite

Job description

Title

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

• 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.

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.

Arthrex Benefits Are

• Medical Insurance (if 25 or more hours per week), including access to telehealth services
• Employee Assistance Program (EAP)
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Volunteer PTO (8 hours)
• Access to the Wellness Center (For South West Florida positions only)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law

Requisition ID:

67404

Title

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.

Arthrex Benefits Are

• Medical Insurance (if 25 or more hours per week), including access to telehealth services
• Employee Assistance Program (EAP)
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Volunteer PTO (8 hours)
• Access to the Wellness Center (For South West Florida positions only)