Engineering, Product Surveillance

Arthrex•Pelican Bay, FL

1d•Onsite

About The Position

Arthrex, Inc., a global medical device company focused on orthopedic product development and medical education, is seeking an Engineer II or Senior Engineer, Product Surveillance for its Global Headquarters in Naples, Florida. Product Surveillance Engineers drive product improvement by conducting and supporting product quality complaint evaluations and investigations, analyzing and trending complaint data, and providing timely customer feedback to stakeholders. The role develops and promotes global product surveillance processes, including policies and procedures. It supports complaint intake, triage, evaluation, reporting, investigation, closure, and trending; performs root cause analysis and device evaluations; and maintains test protocols and records detailed evaluation results. The engineer collaborates with engineering, product management, and quality teams on continuous improvement, represents global complaint processes during audits, assists with regulatory audit responses and information requests, and manages supplier complaint relationships.

Requirements

Engineer II: Bachelor's degree in Engineering and 2 years of engineering experience in a regulated environment.
Engineer II: Previous experience with project management, root cause analysis, and continuous improvement.
Senior Engineer: Bachelor's degree in Engineering and 5 years of engineering experience in a regulated environment.
Senior Engineer: Previous experience with complaint investigation, statistical analysis, project management, root cause analysis, and continuous improvement.
Proficiency with personal computers and software, particularly Microsoft Office applications such as Excel, Word, and PowerPoint, or company-approved equivalents.
Ability to identify opportunities, collect and analyze data, draw valid conclusions, and implement change.
Ability to interpret technical instructions in mathematical or diagram form and work with abstract and concrete variables.
Ability to comprehend and apply mathematical principles required for the job.
Ability to communicate ideas and issues effectively verbally, and to write and record information as required by procedures.

Nice To Haves

Experience with SAP and/or SmartSolve Quality Data.

Responsibilities

Develop and promote global product surveillance processes for medical devices, including developing, managing, and maintaining global policies and procedures.
Perform root cause analysis on returned complaint devices or identified trends, as appropriate.
Maintain test protocols for evaluating returned products against 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.
Represent global complaint investigation, escalation, and trending processes during agency and third-party audits.
Assist with preparation and submission of audit responses and requests for information to the FDA, Notified Bodies, and other regulatory bodies.
Provide timely customer feedback to 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 through receipt of a supplier complaint evaluation.