Engineering, Product Surveillance

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. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer II or Senior Engineer, Product Surveillance for our Global Headquarters in Naples, FL. Product Surveillance Engineers drive product improvement through performing and supporting Product Quality Complaint evaluations and investigations, analyze and trend product quality complaint data, and provide timely customer feedback to key stakeholders. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

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.

• 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)

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.