The individual in this position will perform a variety of manufacturing technician and low level engineering design activities in support of Glaukos' ocular related products manufacturing activities. Responsibilities include building subassembly and top level assemblies

for Glaukos stent systems, developing creative solutions to manufacturing problems, ensuring the proper engineering and operational deliverables are accurately generated, generation of manufacturing and test procedures, and support of other engineering activities. 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) and ISO Standards (ISO 13485).

Job Responsibilities:

Contribute Engineering Project Activities by Planning and Executing Required Product Builds

• Assembles implantable Class III ophthalmic medical devices and the associated insertion system or subcomponents of the device and system.
• Complete component inspection and cleaning per SOPs and DHRs and records all records as required by the QA system.
• Complete subassembly fabrication and inspection per SOPs and DHRs and records all records as required by the QA system.
• Complete top level assembly fabrication and inspection per SOPs and DHRs and records all records as required by the QA system.
• Complete package assembly activities per SOPs and DHRs and records all records as required by the QA system.
• Responsible for generating or editing SOPs and DHRs to support development work.
• Provide support to engineering testing as needed by executing tests methods with detailed to limited definition, depending on the technician level.
• Responsible for generating proper documentation as required by engineering test protocols, engineering test reports, validation protocols, validation reportsand other associated engineering lead task.
• Leads other technicians and team members to ensure project build activities are successful (For Level III and Level IV only).

Other Duties as Assigned

• Additional other duties and projects as required to facilitate Production, Engineering, Clinical and Quality Assurance goals and objectives.

Work Experiance:

• 1 to 3 years engineering or production technician work.
• Medical device experience a plus.

Knowledge, Skills, and Abilities

• Detail oriented with the ability to work in a clean room environment.
• Strong verbal and written communication skills.
• Ability to work with and assemble small, precision parts
• Ability to perform repetitive tasks precisely and consistently.
• Record all traceability information and inventory movement transactions accurately.
• Ability to read and comprehend safety rules, operating and maintenance instruction, procedures manuals, and specifications.
• Excellent eye-hand coordination.
• Experience using micrometers, calipers, and other inspection equipment.
• Experience handling and cleaning medical related part or equivalent.
• Experience working with adhesive dispensing and packaging systems.
• Knowledge of cGMP and ISO regulations a plus

Education:

• Bachelors Degree Requred

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.