Senior Engineer, QA Design - Arthroscopy (Lower Extremeties)

Arthrex•Pelican Bay, FL

About The Position

Arthrex is seeking a Senior Engineer, Design Quality, Lower Extremities, for its global headquarters in Naples, Florida. The Senior Engineer, QA Design interfaces with engineering teams and drives Design Assurance principles for design, development transfer, and post-market surveillance of FDA Class I and II and EU Class I, IIa, IIb, and III medical devices. The role supports company goals and product development, with an emphasis on quality aspects of integrated software, electrical, and/or mechanical device characteristics, as appropriate to the position’s focus. The position leads design assurance for new product introduction projects, supports compliance with design controls and applicable regulations and standards, and guides product risk assessment, usability engineering, and verification and validation activities. It also coordinates design assurance aspects of transferring designs to manufacturing, ensures design history file and other required design control outputs are complete, supports transition into sustaining engineering, and contributes to design-related corrective and preventive activities for pre-sustaining projects.

Requirements

Bachelor’s degree in Engineering.
At least 5 years of design assurance or quality assurance experience in a medical device or other highly regulated industry.
Working knowledge of ISO and FDA design and development quality requirements.
Technical knowledge of development methodologies, design quality analysis, and project implementation.
Proficiency in assessing manufacturing quality requirements of new product concepts.
Proficiency with PC operations, Microsoft Office, and CAD/CAM software.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret a wide variety of technical instructions in mathematical or diagram form and work with abstract and concrete variables.
Ability to comprehend and apply mathematical principles to the degree required by the job.
Ability to comprehend and apply language skills required by the job, communicate ideas and issues effectively to team members and management, and write and record information as required by procedures.

Nice To Haves

Biomedical, Mechanical, or Electrical Engineering degree.
Technical knowledge of GD&T and DOE.
Hands-on experience with SAP and Agile.

Responsibilities

Lead design assurance efforts within product design and development for new product introduction projects, emphasizing quality aspects of integrated software, electrical, and/or mechanical device characteristics as appropriate.
Ensure documented design requirements and outputs are appropriate and traceable throughout the product development lifecycle.
Provide leadership in understanding and implementing regulations and standards, and serve as a resource to other disciplines throughout the product design process from idealization through product retirement.
Supervise, assign, and coordinate the work of others within the design assurance team to support the department, design projects, and goals.
Provide input into and lead the resolution of lessons learned to support development, modification, and improvement of design processes and the quality management system.
Lead product risk assessment activities using applicable standards and tools, including ISO 14971, FMEAs, fault tree analysis, and hazard assessment.
Guide design teams on usability and human factors engineering principles, including IEC 62366 standards and FDA guidance.
Facilitate the planning, execution, and review of verification and validation activities, including assessment of adequate inputs.
Lead and coordinate design assurance for design-to-manufacture transfer, including generating inspection methods, reviewing drawings, determining key product indicators and essential requirements, and, where appropriate, training manufacturing personnel on test procedures, inspection methods, and interpretation of results.
Ensure required design control outputs are met, 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.