MAIN JOB RESPONSIBILITIES / COMPETENCIES
1. Assist in the development and implementation of various Collamer lens manufacturing processes and manufacturing systems to improve the productivity and product quality of STAAR ICL products. Processes to be developed and established at the Lake Forest facility may include, but are not limited to, CNC lathing and milling, laser metrology and engraving, adhesive dispensing, automation, ultrasonic cleaning, tumble polishing, dry and wet lens metrology, sterilization, inspection, packaging, and labeling.
2. Apply project management skills to ensure that tasks are appropriately defined, planned, and documented to ensure on-time completion.
3. Assess processes for their adequacy of methods, equipment, and documentation.
4. Apply statistical and analytical methods such as SPC, Gage R&R, and DOE.
5. Establish test methods, make observations and measurements, interpret data, and write technical reports.
6. Develop manufacturing controls and documentation.
7. Develop and qualify new tooling, equipment, and processes (IQ, OQ, PQ).
8. Train technicians and operators as necessary for protocols and procedures.
9. Support Design Control activities as required.
10. Other duties as assigned.

REQUIREMENTS

EDUCATION & TRAINING
• Bachelor’s Degree in Engineering or equivalent, and demonstrated operational experience.
• Must possess significant knowledge related to medical device manufacturing equipment use and implementation.
• Working knowledge of applicable regulations and standards (i.e. FDA 21 CFR 820 and ISO 13485).
• Working knowledge of contact and non-contact precision measurement equipment.

EXPERIENCE
• Must have minimum of three years of engineering experience in manufacturing of class III medical devices.
• Experience in process improvement methodologies (such as TQM, Lean Manufacturing, and Six Sigma).
• Experience in the utilization of SPC, Gage R&R and DOE methodologies
• Experience in machine controls and utilities, such as mechanical, optical, electrical, software, pneumatic, and fluidic systems.

SKILLS
• Proficient in SolidWorks or other CAD application
• Microsoft Office (Word, Excel, Power Point, etc.)
• Proficient in Excel, Minitab, or other statistical software applications
• Familiar with Enterprise Resource Planning (ERP) Systems
• Sufficient verbal and written skills to communicate and collaborate effectively with all levels
• Analytical and problem-solving skills

Pay range: $85k - $100k Final compensation/salary will be depend on experience

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.