Senior Mechanical Engineer

Welcome to Arthrex we are a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 7,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.

Responsible for full life cycle development of Class I and II medical devices, which includes initiation, design, development, execution, and product maintenance. Recognized as technical leader and resource.

* Expert in CAD (SolidWorks preferred) and experience with tools consistent with mechanical engineering experts (FEA, CFD, PDM, etc.) * Leader in design for quality using risk management tools and lean product development approaches. * Leader in design for manufacturability through coordination with suppliers and internal team members. * Works with marketing and clinical specialists to understand customer needs for products. * Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations. * Leads design development and optimization through prototyping, modeling, simulation and analysis. * Provides expert consultation in one or more areas of design, development, and implementation of technical products or systems. * Recommends alterations to development and design to improve quality of products and/or procedures. * Determines and develops test requirements for components, assemblies and systems as required; support Verification and Validation testing. * Supports development of budgets and timelines for projects. * Gives input to other members of the engineering staff to assist them in their assignments and provide them with learning experience. * Provides expert consultation in one or more areas of design, development, and implementation of technical products or systems. * Supports maintenance of design history file for assigned projects, adhering to Arthrex design control procedures. * Administer and expedite the Design Control Process, DHF management, Design Change Process, Design Verification and Validation in compliance with the QMS and in support of product releases. * Provides Regulatory department technical support for assigned projects as needed. * Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products. * Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed. * Reports progress and status of assigned projects on a timely basis with emphasis on reporting results to Mechanical Engineering Manager. * Some required domestic travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required. **Incidental Duties:** The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

**Education and Experience:** Bachelor of Science Degree in Mechanical Engineering required; MS preferred. Minimum of 7 years of relevant design experience is required. Medical device experience is preferred. **Knowledge and Skill Requirements/Specialized Courses and/or Training:** * Demonstrable experience with product development from concept and testing to production release. Medical device experience preferred. * Expert understanding of electro-mechanical design principals. Motor selection and gearbox design experience preferred. * Expert in 3D-CAD (SolidWorks preferred). * Expert in geometric dimensioning and tolerancing (GD&T), and analysis of tolerance stackup for complex assemblies. * Strong experience with design optimization and simulation with analysis tools such as FEA and CFD. * Demonstrable experience in Design for Manufacturability, including manufacturing process optimization support, and Design for Cost. * Expert understanding of fabrication techniques (e.g. machining, molding, laser cutting, etc.) and associated design tradeoffs. * Strong working knowledge of medical device regulations and associated quality systems, particularly design controls and risk management preferred. * Demonstrable experience in Design for Quality with tools such as FTA, FMEA, HALT/HASS. * Technical knowledge in development methodologies, design, and project implementation. * Knowledge of orthopedic surgery principles, theories, and products preferred. * Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred. * Project management skills and training preferred. * Strong communication skills and accountability to project deliverable timing and budgets required. **Machine, Tools, and/or Equipment Skills:** Working knowledge of mechanical testing equipment, electronic testing equipment, automated test equipment, SolidWorks or other 3D modeling software required. Knowledge of surgical equipment and instrumentation preferred. Experience with Medical Capital Equipment development and testing preferred.