Engineer Sr - Service Sustaining - Medical Devices

Title: Engineer Sr - Service Sustaining - Medical Devices
Division: Arthrex, Inc. (US01)
Location: INC Santa Barbara, CA (ACT) (US17)
Salary Range: $ - $

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Service Sustaining Engineer Sr. I will support product repair center activities throughout the entire product life cycle, and work on continuous improvement of repair quality, cost, and delivery to meet our customer expectations and organization goals; improve processes and cost reduction activities;

and support processes for efficient transfer of product designs to repair operations. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

• Strong understanding and application of principles, concepts, practices, and standards. Deep knowledge of industry practices. Practical knowledge related to the products/components that the position will support, e.g., electromechanical product components and assembly processes.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Develop solutions to complex problems. Refers to policies and practices for guidance.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Refers to established precedents and policies for guidance.
• Work is performed under minimal direction. Participates in determining objectives of assignment. Plans, schedules, and arranges own activities and directs activities of work assignees and team resources to accomplish objectives. Work is reviewed upon completion for adequacy in meeting objectives.
• Knowledge of FDA or ISO guidelines for the investigation and repair of medical devices is preferred.
• Project management experience required.
• Experience in process development preferred.
• Experience creating and updating scope, budget, and schedule of projects required.
• Experience with the proper use of common inspection tools, test equipment, and visual standards required.
• Experience in compiling technical documentation in a regulated industry required.
• Technical guidance to repair center personnel on troubleshooting failures, repairs and evaluating equipment required.
• Ability to communicate technically with team members required.
• Experience in continuous improvement culture, skill sets, and tools to enhance quality and operational excellence required.
• Experience in validating equipment and processes needed for repair and complaint investigation of each new product being developed, qualified, validated and designed for reparability preferred.

• Bachelor's degree in mechanical, electrical, biomedical engineering, or related degree required.
• Master's degree preferred.
• Lean or Six Sigma certification preferred
• 5 years of relevant work experience required.

• Experience with the proper use of common inspection tools, test equipment, and visual standards required.
• Practical knowledge related to the products/components that the position will support, e.g., electromechanical product components and assembly processes required.
• Must be able to read and understand component/product specifications
• Excellent listening skills, including the ability to identify and isolate customers' concerns or objections, in addition to excellent written and oral communication is required
• Six Sigma certification preferred
• Frequent use and general knowledge of industry practices, techniques, and standards, along with general application of concepts and principles preferred
• Knowledge of FDA or ISO guidelines for the investigation and repair of medical devices preferred
• Project management experience preferred
• Experience in continuous improvement culture, skill sets, and tools preferred
• Experience with CNC milling machine and programming preferred

• PC and various specialized software. High efficiency in MS Office suite, including Excel, PowerPoint, Word, Outlook.