Engineer, Research and Development
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of break through products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.
The Engineer, I based in San Clemente, California supports the functions of R&D and Operations in the development of new ophthalmic products with responsibilities that include product development up through design transfer, design control, documentation, engineering and stability studies, quality engineering, and Clinical Study Support.
The Engineer, I will perform a variety of mechanical engineering activities on the ocular related products including product design, concept prototyping, concept testing, and 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).
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:
• Engineer I - With direction from management or senior engineering staff including guidance on task development. Work will be reviewed for accuracy and overall content upon completion. Individual must have the ability to investigate problems.
• CAD Administrator, maintenance of Solidworks Data Vault.
Other Duties as Assigned
• Additional other duties and projects as required
• BS Mechanical Engineering or equivalent required
• MS Engineering or MBA preferred
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation
Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work or in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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