JOB SUMMARY

In support of the manufacture of STAAR products:

1. Provide assistance in troubleshooting/resolving day to day manufacturing issues

2. Identify, source, and pilot new equipment to support process improvements in manufacturing

3. Create and execute validation protocols (IQ, OQ, PQ) and summarize test results as required

4. Create and execute Test Method Validations (TMV) on measurement equipment

5. Optimize process flow and eliminate non-value added steps in product handling; increase efficiencies; and reduce product lead time to Finished Goods Inventory.,

6. Support and lead manufacturing design transfer activities for new products being introduced to production.

7. Conduct root cause analysis for issues found in production

8. Support open non-conforming material reports and CAPAs

9. Liaise with relevant partners in order to drive continuous improvements in manufacturing.

10. Lead facilities update projects to support manufacturing

11. Review and approve process and engineering documents on behalf of Operations

12. Other duties as assigned.

EDUCATION & TRAINING

• Bachelor’s degree in technical discipline or equivalent combination of education/experience.

• Master’s degree in a technical discipline a plus

• Lean/Six Sigma or similar training a plus

EXPERIENCE

• Minimum of 5 years experience in a regulated industry.

• Design transfer experience preferred

• Clean room operations experience a strong plus

• Experience with CAD Design using SolidWorks Preferred

• Experience with Lens Optical Metrology Preferred

• Experience with Optical Lens Machining and Lensing Preferred

• Experience in the medical device industry and working with internal quality and regulatory teams preferred.

• Experience finding, qualifying, and working with manufacturing vendors preferred.

• Experience tracking and troubleshooting yield related issues using data analysis and statistical methods preferred.

SKILLS

• Demonstrated understanding of, and ability to practically implement, cGMP/QSR/ISO requirements

• Excellent team building and interpersonal skills

• Excellent prioritization, multi-tasking and organizational skills

• Ability to lead cross-functional teams to execute projects to planned timeline

• Well versed in lean manufacturing and process improvement

• Working knowledge of requirements around IOL’s or other Class III medical devices

STAAR Surgical is an equal employment opportunity employer.