Sr. Engineer, Research and Development
Glaukos is anophthalmic medical technology company focused on the development andcommercialization of breakthrough products and procedures designed to transformthe treatment of glaucoma, one of the world's leading causes of blindness. Wehave pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize thetraditional glaucoma treatment and management paradigm. We launched the iStent,our first MIGS device, in the United States in July 2012 and we are leveragingour platform technology to build a comprehensive and proprietary portfolio ofmicro-scale injectable therapies designed to address the complete range ofglaucoma disease states and progression. We believe the iStent is the smallestmedical 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 functions of R&D and Operations in the developmentof new ophthalmic products with responsibilities that include productdevelopment up through design transfer, design control, documentation,engineering and stability studies, quality engineering, and Clinical Study Support.
Provides various and specific medicaldevice development expertise related to design control, mechanical design,fixture design, stability, biocompatibility, risk analysis, statisticalrationale and justification, precision micro fabrication, verification andvalidation, inspection, logistics, and vendor coordination.
Designs and Ensures fullycompliant medical device products, focusing on quality during development,clinical, and initial production phases through to design transfer. Ensuresthat quality, capable, fully developed products are transferred to Production.
Assists pilot production andoperations with quantifying and analyzing line performance, identifying anddeveloping process and design improvements inclusive of fixture development.
Supports Sustaining Engineering byleading NCR investigations, corresponding corrective actions and improvementswhere needed.
Participates in or manages all aspectsof the design control process inclusive of authoring Design History Filedeliverables. Assists with Product Development builds by preparing necessarydocumentation and guiding products through Receiving Inspection when needed.Designs and conducts design verification studies, internal/externalproduct/process/equipment validations. Authors V&V plans, V&Vprotocols/reports and test procedures. Conducts design reviews and assists withverification and pilot production builds. Helps define quality requirements fornew products, and writes risk/statistical plans and justifications. Designs andconducts stability studies to establish product shelf life. Supports regulatoryfilings by providing documentation of development activities. Participates inthe design, planning, management and data analysis of Clinical Studies tosupport Product Development.
• Responsible for design control processes for assigned development projects,including conducting design reviews, writing, creating and/or compiling allquality documentation including drawings, specs, DHRs, SOPs, meeting minutes,acting as a key participatory resource and/or Project Manager and workingclosely with other Project Leaders, R&D Engineers, Quality Assurance,Regulatory, Manufacturing and vendors. Creates and maintains Design HistoryFiles until transfer to Quality Assurance at Design Transfer. Assists withProduct Development builds by preparing necessary documentation and guidingproducts through Receiving Inspection when needed. Participates in the design,planning, management and data analysis of Clinical Studies to support ProductDevelopment.
• Responsible for conducting and/or providing technical assistance/oversight indefining and conducting both internal and external product and process testprocedures, V&V plans and protocols, and supporting reports. Will workclosely with other internal product development and manufacturing personnel,Regulatory/Quality departments, and vendors.
• Assisting pilot production and operations with quantifying and analyzing lineperformance, identifying and developing process improvements inclusive offixture development and automation. Support Sustaining Engineering by leadingNCR investigations and corresponding corrective actions.
• Responsible for conducting, documenting and maintaining risk analysis forassigned products and complying with risk analysis, design control, and anyother related procedures, working closely with Subject Matter Expert and otherteam members including CA/RA/QA, Manufacturing, etc.
• Provide technical support to R&D Engineers, Applied Research andManufacturing during the development, clinical, and production phases in areasincluding 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 onothers.
• Minimum 4 years, with 2 years biomedical experience
• Design Control and Documentation: Must possess strong working knowledge,experience, and demonstrated capability in pragmatic application of medicaldevice design controls for FDA and ISO compliance. Strong documentationpractices are critical to the success of this position.
• Metrology: Must have extensive experience in specifications for metal andplastic components and tooling. Familiarity with Smartscope and conventionalprecision inspection a plus, as well as data analysis.
• Statistics: Must be well versed in statistics as applied to medical devicedevelopment, and manufacturing validation.
• Project Leadership: Must have project leadership/management experience andcapacity. Capable of completing a DHF from start to finish.
• Engineering/Microbiology: Must have strong background with demonstratedapplication of skills and knowledge of Mechanical Engineering. Must be fluentin SolidWorks. Must have a good working knowledge of productionmicrobiology including sterilization processes and bioburden control inmanufacturing.
• Design/Verification/Validation/Stability: Strong capability in process,equipment/component design, V&V and stability studies.
• Must have hands-on experience and knowledge in all aspects of Production andInspection of precision medical devices, with Class 7 clean room environmentand Ophthalmology Experience a plus.
• Experience preparing and leading surgeon wetlabs and analyzing gatheredinformation.
• Technical Writing Skills
• Experience working with surgeons in a clinical setting preferred.
• BS, MS preferred in Mechanical Engineering
• Quality Certification a Plus
• SolidWorks Certification a Plus
We offer competitivesalary (based on experience), bonus eligibility, medical/dental/vision,life insurance, stock options, 401(k) Employer Match, 3 weeks paid timeoff, 13 company paid holidays, Employee Stock Purchase Program and 2 additionalpaid days off to volunteer in our community, plus the opportunity towork for a company that is pioneering a new glaucoma treatment class. Check outour profile on The Muse to get an inside look at our companyculture: https://www.themuse.com/companies/glaukoscorporation
Glaukos has beenrecognized by the OrangeCounty Business Journal as one of the best companies to workfor in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
GlaukosCorporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration foremployment without regard to race, color, religion, sex including sexualorientation and gender identity, national origin, disability, protected VeteranStatus, or any other characteristic protected by applicable federal, state, orlocal law.
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