Director, Design Assurance Quality Engineering

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 Director, Design Assurance Quality Engineering who is responsible for the strategic leadership of the corporate quality engineering and risk teams dedicated to the design and development, manufacturing transfer, risk management, and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb, and III medical devices. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™. 

This is an onsite position at Arthrex's corporate headquarters located in Naples, FL.

Essential Duties and Responsibilities:

• Provide leadership and direction to the Design Quality Engineering team in support of new product introductions and sustaining engineering to ensure that products are safe and effective, and released to the market in compliance with Arthrex design control requirements and procedures.
• Provide leadership and direction to the Risk Management team to ensure product and process compliance to 14971 Risk Management requirements while ensuring a closed loop process.
• Maintains a leading-edge understanding of the quality processes required in design and post-market performance in order to find new and novel opportunities to improve product quality, usability/human factors, and risk management while improving design efficiency and reducing time and cost to market.
• Provides Design Assurance project oversight and management, including initiating and leading cross-functional teams dedicated to design assurance improvement and sound risk management processes.
• Manages the overall Risk Management program and team oversite while ensuring compliance to ISO 14971 including risk in design and manufacturing.
• Leads team as an SME in the development of compliant design inputs, user needs, and engineering requirements; ensuring needs can be validated and inputs/requirements can be verified;
• Provides technical assistance to Manufacturing, Quality, and Operations groups throughout the early production build and launch in support of design to manufacturing transfer and risk management.
• Manage team and/or directly participates in all phases of product verification and validation.  Partners with Design Engineering in preparing protocols/test methodologies, developing sample sizes, and establishing acceptance criteria.  Reviews test data, analysis, and final test reports.
• Drives review of the effectiveness of the quality management system’ design and effectively identifies and implements enhancements as necessary to ensure maintenance of state-of-the-art processes and compliance to pertinent international standards and regulatory requirements, e.g., ISO 13485, 21 CFR 820, European MDR, etc., as well as pertinent reference standards such as ISO 14971 and IEC 62366, etc.
• Oversees timely and thorough investigation, root-cause analysis, completion, and effectiveness review of product design-related corrective and preventive actions (CAPA).
• Leads strategic development of team organizational structure, hiring, and developing the quality engineering team and future leaders by actively coaching and providing career development assistance to team members.
• Define and reports progress and status of projects and performance of processes through metric reviews on a timely basis with an emphasis on reporting results to upper management.
• Provides technical support for the manufacture of existing products and the growth and development/transfer of new products/technologies.
• Develops capital plans and budgets for the department.

Education and Experience:

• Bachelor of Science degree in an Engineering field required, master’s degree preferred
• Ten years of related experience in a medical device or similar regulated environment required.
• Ten years of related quality management/supervisory experience required.
• Design Quality Assurance and Risk Management experience in the medical device, aerospace, or other highly regulated industry required.

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

• Working knowledge of design quality processes, risk management, and quality requirements, e.g., design inputs, outputs, verification, validation, etc.
• Design to manufacturing process transfer knowledge.
• Technical knowledge in development methodologies, design quality analysis, and project implementation.

Machine, Tools, and/or Equipment Skills:

PC, Minitab, Solidworks(or similar), Microsoft Office, ERP (SAP, Agile, etc.) software.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. 

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.