Sr. Engineer I
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, I based in San Clemente, California supports the Product Development, Pilot Production, and Operations in the development of new ophthalmic products with responsibilities that include product development up through design transfer, design control, documentation, engineering and stability studies, quality engineering, and Clinical Study Support.
Provides various and specific medical device development expertise related to design control, mechanical design, fixture design, stability, biocompatibility, risk analysis, statistical rationale and justification, precision micro fabrication, verification and validation, inspection, logistics, vendor coordination.
Assists pilot production and operations with quantifying and analyzing line performance, identifying and developing process and design improvements inclusive of fixture development.
Ensures fully compliant product quality during development, clinical, and initial production phases through to design transfer. Ensures that quality, capable, fully developed products are transferred to Production.
Support Sustaining Engineering by leading NCR investigations and corresponding corrective actions.
Participates in or manages all aspects of the design control process inclusive of authoring Design History File deliverables. Assists with Product Development builds by preparing necessary documentation and guiding products through Receiving Inspection when needed. Designs and conducts design verification studies, internal/external product/process/equipment validations. Authors V&V plans, V&V protocols/reports and test procedures. Conducts design reviews and assists with verification and pilot production builds. Helps define quality requirements for new products, and writes statistical plans and justifications. Designs and conducts stability studies to establish product shelf life. Supports regulatory filings by providing documentation of development activities. Participates in the design, planning, management and data analysis of Clinical Studies to support Product Development.
• Responsible for design control processes for assigned development projects, including conducting design reviews, writing, creating and/or compiling all quality documentation including drawings, specs, DHRs, SOPs, meeting minutes, acting as a key participatory resource and/or Project Manager and working closely with other Project Leaders, Product Development Engineers, Quality Assurance, Regulatory, Manufacturing and vendors. Creates and maintains Design History Files until transfer to Quality Assurance at Design Transfer. Assists with Product Development builds by preparing necessary documentation and guiding products through Receiving Inspection when needed. Participates in the design, planning, management and data analysis of Clinical Studies to support Product Development.
• Responsible for conducting and/or providing technical assistance/oversight in defining and conducting both internal and external product and process test procedures, V&V plans and protocols, and supporting reports. Will work closely with other internal product development and manufacturing personnel, Regulatory/Quality departments, and vendors.
• Assisting pilot production and operations with quantifying and analyzing line performance, identifying and developing process improvements inclusive of fixture development and automation. Support Sustaining Engineering by leading NCR investigations and corresponding corrective actions.
• Responsible for conducting, documenting and maintaining risk analyses for assigned products and complying with risk analysis, design control, and any other related procedures, working closely with Subject Matter Expert and other team members including CA/RA/QA, Manufacturing, etc.
• Provide technical support to Product Development Engineers, Applied Research and Manufacturing during the development, clinical, and production phases in areas including validation requirements, statistics, biocompatibility assessment, DFM, risk analysis, FMEA, testing requirements and methods, specifications, vendor quality and other technical items.
• May lead certain projects/project phases and/or participate as team member on others.
• Minimum 5 years
• Design Control and Documentation: Must possess strong working knowledge, experience, and demonstrated capability in pragmatic application of medical device design controls for FDA and ISO compliance. Strong documentation practices are critical to the success of this position.
• Metrology: Must have extensive experience in specifications for metal and plastic components and tooling. Familiarity with Smartscope and conventional precision inspection a plus, as well as data analysis.
• Statistics: Must be well versed in statistics as applied to medical device development, and manufacturing validation.
• Project Leadership: Must have project leadership/management experience and capacity. Capable of completing a DHF from start to finish.
• Engineering/Microbiology: Must have strong background with demonstrated application of skills and knowledge of Mechanical Engineering. Must have a good working knowledge of production microbiology including sterilization processes and bioburden control in manufacturing.
• Design/Verification/Validation/Stability: Strong capability in pragmatic process and equipment/component design and validation as well as designing and conducting verification, validation and stability studies.
• Must have hands-on experience and knowledge in all aspects of Production and Inspection of precision medical devices, with Class 7 clean room environment and Ophthalmology Experience a plus.
• Experience preparing and leading surgeon wetlabs and analyzing gathered information.
• Technical Writing Skills
• Experience working with surgeons in a clinical setting preferred.
• BS, MS preferred in Mechanical or Chemical Engineering or Applicable Science
• Quality Certification a Plus
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.