Job description

Requisition ID: 67600 Title: Engineer II, Product Surveillance Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively searching for an Engineer II, Product Surveillance for our global headquarters in Naples, FL who is responsible for driving product improvement through performing and supporting Product Quality Complaint evaluations and investigations. The Engineer II will also analyze data trends and provide timely 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: • BS Degree in Engineering • 2 years engineering experience in a regulated environment required. • Knowledgeable of Regulatory and ISO guidelines for the development of medical devices required • Knowledgeable of medical device complaint handling and adverse event reporting requirements preferred. • Knowledgeable of product risk management, CAPA, and Nonconformance Reporting preferred 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. Arthrex Benefits • 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 Parental Leave • Paid Time Off • Volunteer PTO • 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.

Requirements

Must-haves

Engineer II, Product Surveillance
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.
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.
BS Degree in Engineering
2 years engineering experience in a regulated environment required.
Knowledgeable of Regulatory and ISO guidelines for the development of medical devices required
Mathematical Skills
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Arthrex Benefits
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Wellness Incentive Program
Free Onsite Medical Clinics
Free Onsite Lunch

Nice-to-haves

Knowledgeable of medical device complaint handling and adverse event reporting requirements preferred.
Knowledgeable of product risk management, CAPA, and Nonconformance Reporting preferred
Annual Bonus

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: successfactors
Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

401(K)

Pto

Paid Time Off

Parental Leave

Wellness