Sr. Engineer II

<strong>At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases&mdash;therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.<br /><br />Help put the next wave of disruptive technologies on the market. Work with a team that&rsquo;s dedicated to making a difference in the lives of patients worldwide.<br /></strong>

San Clemente, CA

Glaukos

Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases. <br /><br />Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.<br /><br />In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases. https://www.glaukos.com/

keywords: leadership,organization,engineering,creative,engineering,assist,mechanical,communication,degree,quality assurance,create,assist,experience,knowledge

Full time

Overview: The Senior Engineer II located in San Clemente, CA 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. &nbsp;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. &nbsp;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&rsquo;s defined development process. &nbsp;Further, all duties shall be performed in a professional way with attention to detail while supporting Glaukos&rsquo; Quality Policy and the appropriated regulatory agencies, including FDA Quality System Regulations (21 CFR &nbsp;820), ISO Standards (EN ISO 13485) and Risk Management (EN ISO 14971).
Responsibilities: <p>Contribute to development of new designs, manufacturing processes, and other engineering / business processes at all stages, from concept creation to production release.</p> <ul> <li>Assists in or develops implantable Class III ophthalmic medical devices and the associated insertion system.</li> <li>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.</li> <li>Responsible for generating proper engineering design models using SolidWorks 3-D parametric modeling software.</li> <li>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.</li> </ul>
Requirements: <ul><li>BS Mechanical Engineering or equivalent required</li><li>MS Engineering or MBA preferred</li><li>5+ years of experience working as design and research engineer</li><li>Strong knowledge of cGMP and ISO regulations required and ability to support regulatory filings and company regulatory / quality audits</li><li>Ability to author V&V and all DHF deliverables.</li><li>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.</li><li>Development work is completed to ensure safe and effective products that meets all worldwide quality, regulatory, marketing requirements. </li></ul>