Senior Design Quality Engineer - Medical Devices Leader

Arthrex, Inc.; Naples (FL); On-site; USD 120,000 - 150,000; Full time

Job summary

Arthrex, Inc. is a global medical device company seeking a Senior Engineer, Design Quality for our Naples, FL headquarters.

This role drives design assurance across engineering teams for design, development transfer and post-market activities in FDA Class I–III devices. The position requires leading design control outputs, risk assessments (ISO14971), and human factors considerations per IEC 62366, with oversight of V&V planning and transfer to manufacturing.

Qualifications

• ISO and FDA design and development quality requirements.
• Technical knowledge in development methodologies, design quality analysis, and project implementation.
• Proficiency in assessing manufacturing quality requirements of new product concepts.
• Technical knowledge in development methodologies, design, and project implementation, including GD&T & DOE.

Responsibilities

• Lead design assurance efforts within product design and development for new product introduction projects with emphasis on quality of integrated software, electrical, and/or mechanical device characteristics.
• Ensure traceability of design requirements throughout the product development lifecycle.
• Provide leadership in understanding/regulations; act as resource to other disciplines in design process from ideation to retirement.
• Supervise and coordinate design assurance team to support projects and goals.
• Lead lessons-learned to improve design processes and the quality management system.
• Lead product risk assessments using ISO14971 and tools like FMEA/FTA.

Skills

Design QA

ISO FDA knowledge

Risk assessment

GD&T DOE

SAP experience

Agile

Education

Bachelor's in Engineering

Tools

CAD/CAM software

SAP

MS Office

Job description

Arthrex, Inc. is a global medical device company seeking a Senior Engineer, Design Quality for our Naples, FL headquarters.

This role drives design assurance across engineering teams for design, development transfer and post-market activities in FDA Class I–III devices. The position requires leading design control outputs, risk assessments (ISO14971), and human factors considerations per IEC 62366, with oversight of V&V planning and transfer to manufacturing.