Senior Validation Engineer
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 Senior Validation Engineer, based in San Clemente, California will be a member of the Research and Development, Engineering organization and will be the subject matter expert for Validations and Risk Management. The Validation Engineer will perform a variety of validation engineering activities based on Risk Management of ocular related products to support product design, concept testing, early development, clinical builds, manufacturing scale up development and sustaining activities. Responsibilities include developing, authoring and executing test methods, test method validation, design V&V and equipment validations (IQ/OQ/PQ), to support all project phases where needed for medical and combination device products. Inclusive of project management pertaining to these activities. This individual will directly interface with the project lead, other engineers, designers, quality, regulatory affairs and the manufacturing staff with a focus on meeting product specifications while complying with the appropriate regulatory agencies, including FDA Quality System Regulations (21 CFR 820), ISO Standards (EN ISO 13485) and Risk Management (EN ISO 14971).
• Execute equipment validations - writing validation protocols, executing IO/OQ/PQ validations, writing validation reports
• Maintaining Equipment
Test Methods and Validations:
• Author test methods, inclusive of gauge R&Rs.
• Train/Assist in the execution and implementation of method validations
• Assist in the execution and implementation of method transfers
• Clear and concise user requirements, product specifications, plans, verification and validation studies, risk management strategies and other relevant design control deliverables.
• Test protocols that include qualified and repeatable test methods, appropriate risk-based sample sizes and clear test instructions that produce meaningful data.
• Robust reports which include appropriately analyzed test data to support regulatory submissions and product launches.
• Transfer plans that include complete DHR/DMR documents, quality control plans, training plans, approved suppliers and process validations.
• Complete and accurate design history files.
• Assist with the maintenance of the risk management plans for assigned product lines ensuring compliance with ISO 14971.
• Integrate risk management throughout all V&V activities.
o Ensure all design control and risk management documents for assigned product are maintained and meet regulatory requirements.
o Participate in investigations for CAPA, manufacturing or quality system projects.
Other Duties As Assigned:
• Additional other duties and projects as required to facilitate R&D Engineering goals and objectives.
Knowledge, Skills, and Abilities:
· Experience with ocular product a plus
· Knowledge of cGMP and ISO regulations a plus
· Ability to interact with all departments a plus
· Detail oriented with the ability to work in a clean room environment.
· Experience with phased new product development processes from concept through full production release.
· Ability to work in team environment as contributor and leader
· Ability to create and maintain scheduled plans while maintaining quality of engineering deliverables with guidance for engineering management.
· Excellent decision making/problem solving skills.
· Strong verbal and written communication skills.
· Proficient in MS Word, Excel, Outlook, and MS Power Point.
· Ability to use MS Project
· Proficient with statistical techniques and Minitab (preferred) or similar
· Appropriate years of experience working as an R&D Engineer, Quality Engineer or Validation Engineer.
· Ability to author test methods, test method validations, V&V protocols and reports.
· Strong knowledge of cGMP and ISO regulations required and ability to support regulatory filings and company regulatory / quality audits
· Ability to manage projects
· 7+ years of experience
· 4+ years of medical device
· 4+ years of mechanical design of complex device assemblies
• BS Mechanical Engineering or Mathematics or equivalent, preferred
• Statistical background 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.