Senior Design Quality Engineer - Medical Devices

Arthrex, Inc.; Naples (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

Arthrex, Inc. is seeking a Senior Engineer, Design Quality, Lower Extremities for its global headquarters in Naples, FL.

The role interfaces with engineering teams to apply Design Assurance principles across design, development transfer, and post-market surveillance of FDA class I-III medical devices. You will lead design assurance activities, drive risk assessment, and ensure regulatory and quality requirements are met throughout the product lifecycle, including design to manufacture transfer

Qualifications

• Bachelor’s degree in Engineering required.
• Minimum 5 years design assurance/quality assurance experience in a medical device or highly regulated industry.

Responsibilities

• Lead design assurance efforts for new product introduction with emphasis on quality.
• Ensure traceability of design requirements throughout the development lifecycle.
• Lead risk assessment activities using ISO14971, FMEAs, FCA, Hazard Assessment.
• Provide guidance on usability/human factors per IEC 62366 and FDA guidance.
• Oversee verification/validation planning, execution, and review.
• Coordinate design to manufacture transfer and inspection method generation.

Skills

Design assurance

Regulatory knowledge

V&V planning

Risk assessment

Education

Bachelor's degree in Engineering

Tools

CAD/CAM

SAP

Agile

Job description

Arthrex, Inc. is seeking a Senior Engineer, Design Quality, Lower Extremities for its global headquarters in Naples, FL.

The role interfaces with engineering teams to apply Design Assurance principles across design, development transfer, and post-market surveillance of FDA class I-III medical devices. You will lead design assurance activities, drive risk assessment, and ensure regulatory and quality requirements are met throughout the product lifecycle, including design to manufacture transfer