American Orthodontics seeks a Product Engineer to lead engineering contributions for a range of products within our extensive line of orthodontic products. This position will lead product development projects as well as provide comprehensive engineering support throughout the product life cycle.
Manage product development projects within a defined Product Development System, beginning with Voice of the Customer concepts through successful steady-state production implementation; directly provide necessary engineering contributions for project success
Coordinate and manage new product introduction schedule and activities, and cross-product issues throughout the product life cycle. Lead quality improvement efforts as required.
Create and manage BOMs and routings for new products
Conduct all appropriate risk management activities related to the design and development of medical devices in compliance with FDA/CE/Health Canada/etc. requirements
Create and manage engineering documentation (including 3-D models, 2-D drawings, Engineering Specifications, manufacturing procedures) necessary for proper manufacturing of products
Define and develop test protocols to evaluate product features and functionality
Define and develop manufacturing processes related to new products; work with process engineers to integrate new products into existing processes
Provide technical support and assist in resolution of manufacturing problems as required
Communicate status of projects to management.
Pursue and support cost reduction activities to achieve established company goals
Review, process, and approve Engineering Change Orders (ECO) applicable to product line responsibilities
Maintain a general awareness of and explore promising new materials and methods applicable to orthodontics products
Develop a deep understanding of manufacturing process capabilities, giving them full consideration during design and development activities
BS Mechanical Engineering and 5+ years experience in product engineering or equivalent required.
Experience with managing product development projects required.
Experience with SolidWorks or equivalent CAD software and MS Office required.
Strong ability to communicate both verbally and in writing is required.
Understanding of FEA techniques, DFM, FMEA, QFD, DOE, SPC, and industrial statistics required.
Demonstrated data-driven problem solving ability required.
Basic understanding of regulatory requirements for medical device design control and manufacturing strongly desired.
Knowledge of Lean Concepts and Six Sigma desired.
Experience with manufacturing process control desired.
Keyword: Engineering, Product, Mechanical,
From: American Orthodontics