Senior Engineer, QA Design - Arthroscopy; Lower Extremeties

Arthrex, Inc.is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Engineer, Design Quality, Lower Extremities for our global headquarters in Naples, FL . The Senior Engineer QA Design 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.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Lead design assurance efforts within product design and development for new product introduction projects with an emphasis in quality aspects of integrated software, electrical, and/or mechanical device characteristics, as appropriate for the specific area of position focus.
• Ensure appropriateness of documented design requirements and outputs while ensuring traceability throughout the product development lifecycle.
• Provide active leadership in understanding and implementing regulations/standards, acting as a resource to other disciplines, within the product design process from idealization through product retirement.
• Supervise, assign, and coordinate others / the work of others within the design assurance team to support the department and design projects and goals.
• Provide input into and lead addressing of lessons learned to support development, modification, and improvement of design processes and quality management system.
• Lead product risk assessment activities through application of a working knowledge of applicable standards (e.g., ISO
  14971, etc.) and tools such as (application, design, process) FMEAs, FTA, and Hazard Assessment.
• Display working knowledge and provide guidance to design teams in the area of usability/human factors engineering principles including standards (IEC 62366) and FDA guidance for compliance.
• Facilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process.
• Lead and coordinate the design assurance aspects of Design to Manufacture Transfer including generation of inspection methods, drawing reviews, determining key product indicators/essential requirements and, where appropriate, training of manufacturing personnel in appropriate test procedures, inspection methods, and interpretation of results.
• Ensure required outputs of the design control process are met, including compliance of the design history file (DHF), and support transition of the design project into sustaining engineering.
• Support design-related corrective and preventative activities for projects in the pre-sustaining phase.

Education and Experience:

• Bachelor’s degree in Engineering required;
  Biomedical, Mechanical, or Electrical Engineering degree preferred.
• 5 years design assurance / quality assurance experience in a medical device or other highly regulated industry required.

Knowledge and Skill Requirements /Specialized Courses and/or Training:

• Working knowledge of 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 but not limited to, GD&T & DOE preferred.

Machine, Tools, and/or Equipment

Skills:

Proficiency with PC operations, and the Microsoft Office suite, and CAD/CAM Software. Hands on experience with SAP and Agile preferred.

Reasoning Ability:

Abilit…