Arthrex - Naples, FL
posted 2 months ago
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 Senior I - QA Design for our global headquarters in Naples, FL. The Senior Design Quality Engineer (DQE) is responsible for interfacing and driving Design Assurance principles within engineering teams for design, development transfer, and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb, and III medical devices in the achievement of company goals. This role is crucial in ensuring that our products meet the highest standards of quality and compliance throughout their lifecycle. In this position, you will lead design assurance efforts within product design and development for new product introduction projects, focusing on the quality aspects of integrated software, electrical, and/or mechanical device characteristics. You will ensure the appropriateness of documented design requirements and outputs while maintaining traceability throughout the product development lifecycle. Your active leadership will be essential in understanding and implementing regulations and standards, acting as a resource to other disciplines within the product design process from idealization through product retirement. You will supervise, assign, and coordinate the work of others within the design assurance team to support departmental and design project goals. Additionally, you will provide input into and lead the addressing of lessons learned to support the development, modification, and improvement of design processes and the quality management system. Leading product risk assessment activities through the application of a working knowledge of applicable standards and tools such as FMEAs, FTA, and Hazard Assessment will also be part of your responsibilities. You will display working knowledge and provide guidance to design teams in usability and human factors engineering principles, ensuring compliance with relevant standards and FDA guidance. Facilitating the planning, execution, and review of verification and validation (v&v) activities will be a key aspect of your role, including assessing adequate inputs to the v&v process. You will lead and coordinate the design assurance aspects of Design to Manufacture Transfer, ensuring that all required outputs of the design control process are met, including compliance of the design history file (DHF). Supporting design-related corrective and preventative activities for projects in the pre-sustaining phase will also be part of your duties.