Engineer II QA Design

Arthrex - Naples, FL

Full-time - Mid Level

Naples, FL

Miscellaneous Manufacturing

About the position

The Engineer II QA Design at Arthrex is responsible for driving Design Assurance principles within engineering teams for the design, development transfer, and post-market surveillance of medical devices. This role focuses on ensuring compliance with FDA and EU regulations while supporting the development of high-quality medical products. The position involves collaboration with various teams to implement quality standards and improve design processes, ultimately contributing to the company's mission of enhancing surgical outcomes.

Responsibilities

• Execute design assurance responsibilities within product design and development for new product introduction projects.
• Ensure appropriateness of documented design requirements and outputs while ensuring traceability throughout the product development lifecycle.
• Support understanding and implementing regulations/standards, acting as a resource to other disciplines in the product design process.
• Lead product risk assessment activities through application of applicable standards and tools such as FMEAs and Hazard Assessment.
• Provide guidance to design teams in usability/human factors engineering principles and compliance standards.
• Facilitate the planning, execution, and review of verification/validation activities.
• Coordinate design assurance aspects of Design to Manufacture Transfer, including generation of inspection methods and training of manufacturing personnel.
• Ensure compliance of the design history file and support transition of the design project into sustaining engineering.
• Support design-related corrective and preventative activities for projects in the pre-sustaining phase.

Requirements

• Bachelor's degree in Engineering required
• 2+ years experience in Design Quality Assurance required, preferably in a medical device or other highly regulated industry.
• Knowledge of ISO and FDA design and development quality requirements.
• Technical knowledge in development methodologies, design quality analysis, and project implementation.

Nice-to-haves

• Technical knowledge in GD&T & DOE preferred.
• Hands-on experience with SAP and Agile preferred.

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)