Engineer I QA Design - Orthobiologics

Arthrex • Pelican Bay, FL

54d • Onsite

About The Position

Arthrex, Inc. is seeking an Engineer I, QA Design - Orthobiologics for its global headquarters in Naples, Florida. The role is responsible for applying and driving Design Assurance principles within engineering teams across design, development transfer, and post-market surveillance for FDA Class I and II and EU Class I, IIa, IIb, and III medical devices.

The position supports product design and development, with a focus on quality aspects of integrated software, electrical, and/or mechanical device characteristics. It leads or supports regulatory compliance, design controls, risk assessment, usability, verification and validation, and design-to-manufacturing transfer. The role also supports design history file compliance, transition to sustaining engineering, and design-related corrective and preventive activities before projects enter the sustaining phase.

Requirements

• Bachelor's degree in Engineering.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret a wide range of technical instructions in mathematical or diagram form and work with abstract and concrete variables.
• Ability to comprehend and apply mathematical principles as required by the job.
• Ability to comprehend and apply language skills required by the job.
• Ability to communicate ideas and issues effectively verbally to team members and management.
• Ability to write and record data and information according to procedures.

Nice To Haves

• Experience in Design Quality Assurance in the medical device industry or another highly regulated industry.

Responsibilities

• Execute design assurance responsibilities for new product introduction projects, focusing on quality aspects of integrated software, electrical, and/or mechanical device characteristics as appropriate to the role.
• For electrical equipment or active-device projects, lead compliance efforts for electrical safety, environmental requirements, and emissions under national and international regulations.
• Ensure documented design requirements and outputs are appropriate and traceable throughout the product development lifecycle.
• Support understanding and implementation of applicable regulations and standards, serving as a resource to other disciplines throughout the product design process.
• Provide input into and lead the resolution of lessons learned to develop, modify, and improve design processes and the quality management system.
• Lead product risk assessment activities using applicable standards and tools such as FMEAs, fault tree analysis, and hazard assessment.
• Guide design teams on usability and human factors engineering principles, including IEC 62366 and FDA guidance.
• Facilitate planning, execution, and review of verification and validation activities, including assessment of inputs to the process.
• Coordinate design assurance aspects of design-to-manufacture transfer, including generating inspection methods, reviewing drawings, determining key product indicators and essential requirements, and training manufacturing personnel where appropriate.
• Ensure required design control outputs are completed, including design history file compliance, and support transition of design projects into sustaining engineering.
• Support design-related corrective and preventive activities for projects in the pre-sustaining phase.

Benefits

• Medical, dental, and vision insurance
• Company-provided life insurance
• Voluntary life insurance
• Flexible Spending Account (FSA)
• Supplemental insurance plans, including accident, cancer, hospital, and critical illness coverage
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level