Principal Mechanical Engineer

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Glaukos is an equal opportunity employer and makes employment decisions on the basis of merit. Glaukos participates in E-Verify. The Company policy prohibits discrimination based on race, color, creed, gender, gender identity, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, sexual orientation, covered veteran status, or any other consideration made unlawful by applicable federal, state, or local laws. It also prohibits unlawful discrimination based on the perception that anyone has any of those characteristics, or is associated with a person who has or is perceived as having any of those characteristics.

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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. 

Position Overview:

The Principal Mechanical Engineer, 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).

 

Responsibilities:  

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.

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: 

•           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 assist in reviews of other engineers work for accuracy and content.  Individual will lead key strategic engineering projects and investigations with limited or no guidance.  Subject Matter Expert in a given technical area.

•           Other Duties as Assigned

•           Additional other duties and projects as required

 

Work Experience:   

Knowledge, Skills, and Abilities:

•           Experience with ocular product a plus

•           General for all Levels

o          Detail oriented with the ability to work in a clean room environment.

o          Experience with phased new product development processes from concept through full production release.

o          Ability to work in team environment as contributor and leader

o          Ability to create and maintain scheduled plans while maintaining quality of engineering deliverables with guidance for engineering management.

o          Excellent decision making/problem solving skills.

o          Strong verbal and written communication skills.

o          Proficient in MS Word, Excel, Outlook, and MS Power Point.

o          Ability to use MS Project (Only for senior levels – Senior I and up).

o          Appropriate years of experience working as design and research engineer

o          SME for certain elements of cGMP and ISO regulations and ability to support or lead technical elements of regulatory filings and company regulatory / quality audits

o          Ability to be a technical leader on key development projects

o          12+ years of experience

o          6+ years of medical device

o          6+ years of mechanical design of complex device assemblies

o          Technical lead for 4+ years managing multiple technologies

Education:

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, 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.

 

 

 

 

Location: Engineering in San Clemente, CA
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Apply at: https://glaukos.synchr-recruit.com/job/90780/principal-mechanical-engineer