Manufacturing Engineer II

<p class=""p1"">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p>

Aliso Viejo, CA


<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4>

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Full time


Overview: <ul> <li>Developing manufacturing processes, production scale-up, and sustaining support</li> <li>Developing creative solutions to manufacturing problems</li> <li>Development and execution of process, equipment, and product validations/qualifications</li> <li>Ensuring engineering deliverables are accurately generated, via 3D CAD models and 2D CAD drawings for assembly tools, fixtures, and clinical supplies</li> <li>Leading manufacturing related project teams (i.e. engineers, technicians, and manufacturing staff) with a focus on meeting manufacturing requirements while taking a high quality/cost effective approach.</li> </ul>
Responsibilities: <p>Duties shall be performed with attention to detail while supporting Glaukos&rsquo; Quality Policy and the appropriated regulatory agencies, including FDA Quality System Regulations (21 CFR 820 and 210/211) and ISO Standards (ISO 13485).</p> <ul> <li>Author SOPs, WIs, DHRs, MBRs, and Quality Events</li> <li>Work closely with production team to ensure continual process improvement</li> <li>Author and/or execute Equipment Qualification Protocols and Reports (IQ/OQ/PQ)</li> <li>Author pFMEAs</li> <li>Train Operators, Technicians and Inspectors on processes or procedures</li> <li>Ensure outside vendor timelines allow for Glaukos to meet production/project schedules</li> <li>Continuously improve pharma/device related processes and procedures to ensure the department&rsquo;s operational success</li> <li>Member of the audit and inspection readiness team</li> <li>Ensure area and documentation readiness</li> <li>Direct interaction with internal and external groups: Vision ID, Regulatory, R&amp;D, Supply Chain, Operations, Quality, and vendors</li> <li>Lead certain projects/project phases and/or participate as team member on others</li> <li>Team player and self-starter</li> <li>Solid written and oral communication skills</li> <li>Able to thrive in a small, entrepreneurial environment</li> <li>Must be organized and able to coordinate activities with internal departments and outside vendors</li> </ul>
Requirements: <ul><li>A Master’s degree in Mechanical, Biomedical, Chemical Engineering or equivalent with 0-2+ years of operational experience is preferred</li><li>A Bachelors’ degree in Mechanical, Biomedical, Chemical Engineering or equivalent with 1-3 years of operational experience is preferred</li><li>1-3 years of experience in a pharma/biotech/med device company is preferred</li><li>Ability to manage simultaneous projects and report progress/challenges to upper management</li><li>Possess strong problem solving skills</li><li>Strong Technical Writing, Presentation, and Communication Skills</li><li>Pharmaceutical and/or Combination Product development and manufacturing knowledge desired</li><li>Must be well versed in statistics as applied to product/process validation.</li><li>Perform the job in a quality system and regulated environment.</li><li>Strong Mechanical Design and Analysis skills, including Solidworks proficiency desired. </li></ul>