Engineer Senior - QA Design; Electromechanical

Engineering - Santa Barbara, CA, US, 93111

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 an Engineer, Sr. I – QA Design who 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™.

• 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.
• For electrical equipment / active device projects, lead compliance efforts for electrical safety, environmental, and emissions in accordance with national and international regulations.
• 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.
• 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.

• 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.

Working knowledge of ISO and FDA design and development quality requirements.

Technical knowledge in development methodologies, design quality analysis, and project implementation.

Basic knowledge in Electro-Medical safety standards - IEC 60601-1 (Electrical safety), IEC 60601-1-2 (EMC), and other Collateral and Particular standards.

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.

Proficiency with…