Location: Santa Barbara
Posted on: November 9, 2018
Requisition ID: 41499 Title: Engineer - Mechanical Division: Arthrex, Inc. (US01) Location: INC Santa Barbara, CA (ACT) (US17)
Responsible for supporting development of Class I and II medical devices, which includes initiation, design, development, execution, and product maintenance. Recognized as technical leader and resource.
Essential Duties and Responsibilities:
- Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.
- Provides 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.
- Supports maintenance of design history file for assigned projects, adhering to Arthrex design control procedures.
- Provides Regulatory department technical support for assigned projects as needed.
- May support marketing with technical information to be used for training and marketing of assigned products.
- Supports Manufacturing to provide processing improvements.
- Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
- Determines necessity of testing and initiates testing of assigned products
- Reports progress and status of assigned projects on a timely basis to Mechanical Engineering Manager.
- May require travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.
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 Electrical or Mechanical Engineering required
3 years of relevant on the job experience is required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Experience with product development from concept and testing to production release
- Understanding of electro-Mechanical and electro-Optical design principals.
- Expert in 3D-CAD (e.g. SolidWorks).
- Some experience with design optimization and simulation with analysis tools such as FEA and CFD.
- Demonstratable experience in Design for Manufacturability, including manufacturing process optimization support, and Design for Cost.
- Understanding of quality systems, particularly design controls and risk management.
- Understanding of medical device regulations preferred.
- Experience in Design for Quality with tools such as FTA, FMEA, HALT/HASS.
- Manufacturing process knowledge preferred.
- Technical knowledge in development methodologies, design, and project implementation.
- Knowledge of endoscopic surgery prefered.
- Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred.
- Strong communication skills and accountability to project deliverable timing and budgets required.
Machine, Tools, and/or Equipment Skills:
Knowledge of mechanical testing equipment, PC, SolidWorks or other 3D modeling software required.
Experience with Medical Capital Equipment development and testing, surgical equipment and instrumentation preferred.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Keywords: Arthrex, Santa Barbara , Mechanical Engineer, Engineering , Santa Barbara, California
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