Product Surveillance Engineer — Quality & Investigations

Arthrex; Naples (FL); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

Voluntary Life Insurance

Flexible Spending Account (FSA)

Supplemental Insurance Plans (Accident

Cancer

Hospital

Critical Illness)

Matching 401(k) Retirement Plan

Annual Bonus

Wellness Incentive Program

Free Onsite Medical Clinics

Free Onsite Lunch

Tuition Reimbursement Program

Trip of a Lifetime

Paid Time Off

Employee Assistance Provider (EAP)

Job summary

Arthrex, Inc. in Naples, FL, seeks Engineer II or Senior Engineer, Product Surveillance to drive medical device quality improvements. Responsibilities include evaluating complaints, root cause analysis, data trending, and cross-functional collaboration with Design, Manufacturing, Product Management and Quality teams.

The role supports FDA and regulatory audits and timely stakeholder feedback. The position emphasizes global surveillance processes, data-driven investigations, supplier engagement,

Qualifications

• Bachelor's Degree in Engineering required.
• 2 years engineering experience in a regulated environment required (Engineer II).
• 5 years engineering experience in a regulated environment required (Engineer Sr).

Responsibilities

• Develop and promote the Arthrex Product Surveillance processes for medical devices.
• Perform root cause analysis for returned complaint devices or identified trends.
• Maintain test protocols to evaluate returned product against specifications.
• Partner with Design Engineering, Manufacturing Engineering, Product Management, and Quality Engineering to drive improvements.
• Function as global representative for complaint investigation and audits to FDA and other bodies.
• Provide timely customer feedback through root cause and statistical analysis.
• Support global complaint triage, intake, evaluation, reporting, investigation, closure and trending.
• Manage supplier relationships from notification to supplier complaint evaluation.

Skills

Root cause analysis

Statistical analysis

Project management

Continuous improvement

Education

Bachelor's Degree in Engineering

Tools

SAP

SmartSolve

Job description

Arthrex, Inc. in Naples, FL, seeks Engineer II or Senior Engineer, Product Surveillance to drive medical device quality improvements. Responsibilities include evaluating complaints, root cause analysis, data trending, and cross-functional collaboration with Design, Manufacturing, Product Management and Quality teams.

The role supports FDA and regulatory audits and timely stakeholder feedback. The position emphasizes global surveillance processes, data-driven investigations, supplier engagement,