Engineer I

<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/

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Full time

Overview: Located in San Clemente, CA, the Engineer I&nbsp;will 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;
Responsibilities: <ul> <li>Contribute to the development of new designs, manufacturing processes, amd other engineering/business processes at all stages, from concept creation to production release.</li> <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> <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.&nbsp;This works is accomplished with direction from management or senior engineering staff including guidance on task development.&nbsp;</li> <li>Work will be reviewed for accuracy and overall content upon completion.&nbsp; Individual must have the ability to investigate problems.</li> </ul>
Requirements: <p><strong>Education:</strong></p> <ul> <li>Bachelors&nbsp;degree required;&nbsp;BS Mechanical Engineering or equivalent, preferred.</li> </ul> <p><strong>Requirements:</strong></p> <ul> <li>0+ years engineering work.</li> <li>Medical device experience a plus.</li> <li>Experience with ocular product a plus.</li> <li>Detail oriented with the ability to work in a clean room environment.</li> <li>Experience with phased new product development processes from concept through full production release.</li> <li>Ability to work in team environment as contributor and leader.</li> <li>Ability to create and maintain scheduled plans while maintaining quality of engineering deliverables with guidance for engineering management.</li> <li>Excellent decision making/problem solving skills.</li> <li>Strong verbal and written communication skills.</li> <li>Proficient in MS Word, Excel, Outlook, and MS Power Point.</li> <li>Ability to use MS Project (Only for senior levels &ndash; Senior I and up).</li> <li>Knowledge of cGMP and ISO regulations a plus.</li> <li>Ability to fabricate assemblies under a microscope.</li> <li>Ability to interact with all departments a plus.</li> <li>SolidWorks capable, part, assembly and drawing generation.</li> </ul>