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Principal Mechanical Engineer

Company: Glaukos Corporation
Location: San Clemente
Posted on: January 17, 2019

Job Description:

The Principal Mechanical Engineer, perform a variety of mechanical engineering activities on the ocular related products including product design, concept prototyping, concept testing, early development, clinical builds, manufacturing scale up development and sustaining activities. Responsibilities include developing creative solutions to design and manufacturing problems, ensuring the proper engineering deliverables are accurately generated, generation of 3D CAD models, 2D CAD drawings, test procedures, etc., project management/ leadership, maintaining schedule and product release plans. This individual will may lead project teams with other engineers, designers, and manufacturing staff with a focus on meeting product specifications with technically strong, high quality, cost effective designs following Glaukos's defined development process. Further, all duties shall be performed in a professional way with attention to detail while supporting Glaukos' Quality Policy and the appropriated regulatory agencies, including FDA Quality System Regulations (21 CFR 820), ISO Standards (EN ISO 13485) and Risk Management (EN ISO 14971). Responsibilities: CONTRIBUTE TO DEVELOPMENT OF NEW DESIGNS, MANUFACTURING PROCESSES, AND OTHER ENGINEERING / BUSINESS PROCESSES AT ALL STAGES, FROM CONCEPT CREATION TO PRODUCTION RELEASE. --- Assists in or develops implantable Class III ophthalmic medical devices and the associated insertion system. --- Responsible for applying fundamental and advanced (depending on level) mechanical engineering principles, concepts, theories and techniques to solve complex problems related to product development / design and manufacturing while following company standard practices and procedures, and related specification. --- Responsible for generating proper engineering design models using SolidWorks 3-D parametric modeling software. --- Responsible for generating proper documentation including detailed 2-D part drawings, assembly drawings, engineering test protocols, engineering test reports, validation protocols , validation reports and other associated engineering documentation using, SolidWorks, MS Office Suite, etc. while ensuring proper engineering control guidelines are met and the appropriated level of detail is used. CONTRIBUTE TO DEVELOPMENT OF NEW DESIGNS, MANUFACTURING PROCESSES, AND OTHER ENGINEERING / BUSINESS PROCESSES AT ALL STAGES, FROM CONCEPT CREATION TO PRODUCTION RELEASE. --- Assists in or develops implantable Class III ophthalmic medical devices and the associated insertion system. --- Responsible for applying fundamental and advanced (depending on level) mechanical engineering principles, concepts, theories and techniques to solve complex problems related to product development / design and manufacturing while following company standard practices and procedures, and related specification. --- Responsible for generating proper engineering design models using SolidWorks 3-D parametric modeling software. --- Responsible for generating proper documentation including detailed 2-D part drawings, assembly drawings, engineering test protocols, engineering test reports, validation protocols , validation reports and other associated engineering documentation using, SolidWorks, MS Office Suite, etc. while ensuring proper engineering control guidelines are met and the appropriated level of detail is used. --- Assists in or development completed per project plan with defined milestones, which are defined by the project engineer, but approved by the team and management. --- Development work is completed to ensure safe and effective products that meets all worldwide quality, regulatory, marketing requirements. This works is accomplished with: --- With limited direction from department director or Vice President including limited or no guidance on task development. Work is typically not reviewed for accuracy and overall content upon completion. Further, this engineer will assist in reviews of other engineers work for accuracy and content. Individual will lead key strategic engineering projects and investigations with limited or no guidance. Subject Matter Expert in a given technical area. --- Other Duties as Assigned --- Additional other duties and projects as required Work Experience: Knowledge, Skills, and Abilities: --- Experience with ocular product a plus --- General for all Levels o Detail oriented with the ability to work in a clean room environment. o Experience with phased new product development processes from concept through full production release. o Ability to work in team environment as contributor and leader o Ability to create and maintain scheduled plans while maintaining quality of engineering deliverables with guidance for engineering management. o Excellent decision making/problem solving skills. o Strong verbal and written communication skills. o Proficient in MS Word, Excel, Outlook, and MS Power Point. o Ability to use MS Project (Only for senior levels - Senior I and up). o Appropriate years of experience working as design and research engineer o SME for certain elements of cGMP and ISO regulations and ability to support or lead technical elements of regulatory filings and company regulatory / quality audits o Ability to be a technical leader on key development projects o 12 years of experience o 6 years of medical device o 6 years of mechanical design of complex device assemblies o Technical lead for 4 years managing multiple technologies Education: o BS Mechanical Engineering or equivalent required o MS Engineering or MBA preferred

Keywords: Glaukos Corporation, San Clemente , Principal Mechanical Engineer, Engineering , San Clemente, California

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