Job Description

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).

What You Will Do:

• Contribute to the development of new designs, manufacturing processes and other engineering & business procceses at all stages, from concept creation to product 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 development of 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 meet all worldwide quality, regulatory, marketing requirements.
  overall content upon completion. Individual must have the ability to lead projects and investigations with limited guidance.
• Other duties as assigned

• Bachelor's Degree BS Mechanical Engineering or equivalent Required
• Master's Degree MS Engineering or MBA Preferred
• 5+ years' work experience. Required
• 2+ years at E2 Required
• 2+ years of medical device experience Required
• Experience with ocular product Preferred
• Detail oriented with the ability to work in a clean room environment. Required
• Experience with phased new product development processes from concept through full production release. Required
• Ability to work in team environment as contributor and leader Required
• Ability to create and maintain scheduled plans while maintaining quality of engineering deliverables with guidance for engineering management. Required
• Excellent decision making/problem solving skills. Required
• Strong verbal and written communication skills. Required
• Proficient in MS Word, Excel, Outlook, and MS Power Point. Required
• Ability to use MS Project Required
• Knowledge of cGMP and ISO regulations Preferred
• Ability to fabricate assemblies under a microscope. Required
• Ability to interact with all departments Preferred
• SolidWorks capable, part, assembly and drawing generation. Required
• Appropriate years of experience working as an engineer on complex subassembly, top level assembly, fixtures, tooling and product builds. Required
• 2+ years of experience working with a wide range of manufacturing methods, including machined, extruded, molded and laser cut parts. Required
• Ability to interact with all departments . Required
• Ability to coordinate activities with outside vendors. Required
• Ability to author V&V and some DHF deliverables with guidance. Required
• Appropriate years of experience working as design and research engineer Required
• Strong knowledge of cGMP and ISO regulations Required
• Ability to author V&V and some DHF deliverables. Required

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

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.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.