Sr. Engineer I - Service Sustaining - SC

Arthrex•Pendleton, SC

5d•Onsite

About The Position

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 Sr. Engineer I - Service Sustaining for our Pendleton, SC location. This position supports product repair center activities throughout the entire product life cycle, and works on continuous improvement of repair quality, cost, and delivery to meet our customer expectations and organizational goals. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™. Main Objective: Supports product repair center activities throughout the entire product life cycle, and works on continuous improvement of repair quality, cost, and delivery to meet our customer expectations and organization goals. Improves processes and cost reduction activities. Supports processes for efficient transfer of product designs to repair operations.

Requirements

Bachelor’s degree in engineering required, preferably in mechanical, electrical, biomedical engineering.
5 years of relevant work experience required.
Knowledge of FDA or ISO guidelines for the investigation and repair of medical devices 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.
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.

Nice To Haves

Master’s degree preferred.
Lean or Six Sigma certification preferred.

Responsibilities

Contributes to new projects for key improvement initiatives, identifies best practices by multifunctional project teams to bring new products to repair lines.
Supports the design and development of the necessary tools and jigs for repair of products in service channels, and field and repair center.
Provides test engineering support through optimizing test procedures and test equipment.
Works with cross-functional product design teams to validate equipment and processes required for repair and complaint investigations during design for reparability, qualification, and validation.
Collects and analyzes Root Cause Investigation data to help with Root Cause Investigation/CAPA.
Works with the Design Engineering team on identifying needs for design improvements.
Participates in Kaizen events targeting key improvements to drive productivity improvements.
Analyzes repair data using statistical analysis tools such as Mean Time Between Failures (MTBF) to identify and reverse any adverse trends.
Identifies and supports the delivery of training needed for repair center personnel.
Participates in projects aligned with the repair lines strategy.
Travels up to 25% domestically and internationally.