** Position Description**
Advanced Manufacturing Technician IV Location Lake Forest, CA, US Job Code 1220 # of Openings 1 MAIN JOB RESPONSIBILITIES / COMPETENCIES
- Perform highly technical tasks in manufacturing of Implantable Lenses (ICL).
- Follow all applicable SOPs including Production Control, Environmental Control, Good Documentation Practice and Work Instruction procedures. Legibly document process records on Device History Record Forms.
- Assist with and performs engineering studies, accurately document test results, provide detailed insight into positive and negative results of test.
- Perform in-process calibration of all manufacturing metrology as required.
- Perform CNC lathe diamond tool exchange and calibration. Create equipment calibration records per procedure.
- Perform ICL in-process inspection utilizing microscopes, interferometers and drop gauges etc.
- Support engineering studies with equipment setup, equipment calibration and test sample fabrication.
- Perform routine equipment PM on CNC lathe and other equipment. Conduct equipment failure investigation as necessary for unplanned maintenance.
- Train production operators on manufacturing operations.
- Other duties as assigned.
EDUCATION & TRAINING
• Must possess a high school diploma or general education diploma (GED) or equivalent combination of education/experience.
• Highly skilled precision lathe operator, Optoform precision lathe setup and operation is a must.
• Minimum 10 years of experience in medical device manufacturing environment, with minimum 7 years of direct experience in precision IOL, ICL or Contact Lens machining utilizing Optoform 40 or Optoform 80 CNC lathes preferred.
• Experienced in diamond tool exchange and tool setting calibration.
• Highly skilled in in-process inspections utilizing interferometers, microscopes, drop gauges and other metrology instrumentation.
• Experience with an ISO 13485 or cGMP manufacturing environment.
• Being able to provide operational job training to other technicians.
• Highly skilled in precision manufacturing equipment, including using Precitech Sterling Optoform 40 optical lathe to manufacture prototype or final product ophthalmic lenses.
• Proven competence operating IOL, ICL analytical instruments, such as laser micrometer for dimensional measurements, lens power and MTF analysis instruments, radius gauge or interferometer for lens surface radius and surface quality inspection.
• Excellent documentation skills with specific experience with Class III medical device manufacturing process documentation.
• Must be able to read, write, and speak English.
• Be able to communicate with co-workers at all levels.
• Must possess good manual dexterity, technical aptitude and ability to identify process problems.
• Ability to take direction from lead/supervisor and contribute to departmental goals.
• Adaptable to different operational tasks in a growing business environment.
• Being able to lift load under 20 lbs.
• Basic computer skills strongly preferred.
STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.