Sr. Principal Engineer
Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world’s leading causes of blindness.
The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its 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.
The company’s second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, California.
The Senior Principal Engineer, based in San Clemente, California, 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. 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.
• Senior Principal Engineer – 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 often review all engineers work for accuracy and content. Individual will lead key strategic engineering projects and investigations with no technical guidance and some management guidance. Subject Matter Expert in two or more technical areas.
• Senior Principal Engineer
o 15+ years of experience
o 8+ years of medical device
o 8+ years of mechanical design of complex device assemblies
o Technical lead for 6+ years managing multiple technologies and multi-discipline teams
o All requirements from Principal Engineer
o Appropriate years of experience working as design and research engineer
o SME for certain elements of cGMP and ISO regulations and ability to lead technical elements of regulatory filings and company regulatory / quality audits
o Ability to be a project or technical leader on key development projects
In addition to the above requirements, this role will be a key Project Management position, so I’d like to have the additional items:
• 10+ years of experience in medical device project leadership / management
• Experience leading teams of engineers, quality representatives, regulatory representatives, and operation representatives. Teams up to 20 people!
• Approximately 60 to 75% of the position time will be project management, and the balance will be supporting engineering validation and project activities.
o BS Mechanical Engineering or equivalent required
o MS Engineering or MBA preferred
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, restricted stock units, 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 Register as one of the best companies to work for in in Orange County, check out the link https://www.ocregister.com/2018/12/07/top-workplaces-2018-see-the-list-of-all-140-orange-county-honorees/
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.