Sr. Engineer, R&D
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough 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 Sr. Engineer, R&D based in San Clemente, California will perform a variety of mechanical engineering activities on ocular related products including product design, concept proto, concept testing, early development and 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 and leadership, and 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) and ISO Standards (ISO 13485).
Contribute to Development of New Designs, Manufacturing Process, 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 including limited or no guidance on task development. Work may be reviewed for accuracy and overall content upon completion. Individual must have the ability to lead projects and investigations with limited guidance.
In support of the above actions, the following specific items are defined as key skills.
o Basic or advance knowledge of medical device environment and associated quality and regulatory standards
o Experience with micro-machine part
o Knowledge of molded parts
o Test method development
o Validation protocol development
o Data acquisition using load cells, video measurement systems, high speed video system, and hand held measurement systems.
o Data processing and analysis using statistics including software tools like Minitab
o Test report development
o Validation report development
o Ability to complete complex assembly operations and develop operating procedures with a high level of accuracy on the first attempt
o Ability to develop device history recording documents with a high level of accuracy on the first attempt
o Ability to maintain a proper engineering revision control
o Ability to maintain proper CAD data management
o Ability to lead and complete change orders
o High level of attention to detail.
Perform Others Duties as Assigned:
• Clinical and Quality Assurance goals and objectives.
• 8 to 12 years work experience.
• 4+ years of medical device experience required, 8+ years preferred.
• 2+ years of project or technical leadership experience required, 4+ preferred.
• Detail oriented with the ability to work in a clean room environment.
• Experience with phased new product development processes from concept through full production release.
• Ability to work in team environment as contributor and leader
• Ability to create and maintain scheduled plans while maintaining quality of engineering deliverables with guidance for engineering management.
• Excellent decision making/problem solving skills.
• Strong verbal and written communication skills.
• Proficient in MS Word, Excel, Outlook, and MS Power Point.
• Ability to use MS Project
• Experience with ocular product a plus.
• 4+ years or experience working as mechanical engineering on complex medical device subassembly and top level assembly builds.
• 2+ years of project or technical leadership experience.
• Strong knowledge of cGMP and ISO regulations required.
• Experience with MRP required.
• 5+ years Solidworks or equivalent experience.
• 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 for 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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