American Orthodontics seeks a Materials Engineer to support the design, development, and manufacturing process for our extensive line of orthodontic products. This position will provide comprehensive materials engineering support throughout the product life cycle.
The candidate will be responsible for the selection and development of metallic and nonmetallic and fabrication processes in support of the design and manufacture of orthodontic products; scope of nonmetallic materials will include ceramics, plastics, composites, and elastomers, along with organic and inorganic coatings.
Performs complex assignments often requiring development of new or improved materials/processes/fabrication and assembly techniques, and associated data-sets.
Applies sound materials and materials processing principles in the selection of materials and component development with regard to strength, reliability, corrosion resistance, and biocompatibility for design optimization.
Works with cross functional teams including manufacturing, quality, regulatory, and supply chain personnel to resolve design, production, quality or regulatory issues; uses appropriate techniques to solve problems and develop efficient and sustainable manufacturing practices.
Contributes to appropriate risk management activities related to the design and development of medical devices in compliance with FDA/CE/Health Canada and all other global regulatory agency requirements.
Contributes to successful product development project completion by participating in material/process specification and data development for the design and manufacture of orthodontic products.
Develops project-related data for new or improved materials/processes/fabrication and assembly techniques with coordinated regulatory approval.
Assesses industry trends and opportunities for new technologies and implements investigative research and development initiatives to advance competitive designs.
Keeps abreast of emerging materials and coatings technologies applicable to orthodontic products; where appropriate, works with academic or other research institutions to advance the development of novel materials for use in orthodontic products.
Assists in the resolution of technical issues such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements.
Appropriately treats, evaluates, and interprets data generated in manufacturing processes (such as process control and loss data) or from experimental results, through statistical analysis, data presentation, etc., for the purposes of understanding trends, making predictions, and communicating effectively in the workplace.
Reviews project-related documentation, including supplier material and process specifications, design data and qualification/substantiation data to ensure its accuracy.
Participates in professional organizations to maintain current knowledge of technical innovations.
Assists in determining project objectives to contribute to the development of a comprehensive project design.
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors; has working knowledge of appropriate analysis techniques and instrumentation to obtain necessary information.
BS Materials Engineering and 3 - 5 years’ experience in materials and process engineering or equivalent required.
Strong ability to communicate both verbally and in writing is required.
Experience with manufacturing process control required.
Demonstrated data-driven problem solving ability required.
Understanding of materials analysis techniques, DOE, SPC, and industrial statistics required.
Basic understanding of regulatory requirements for medical device design control and manufacturing strongly desired.
Knowledge of Lean Concepts and Six Sigma desired.
Keyword: Materials Engineer, process, structure, product development
From: American Orthodontics