Manufacturing Science & Technology Engineer II

About the role

Staar Surgical is hiring a Manufacturing Science & Technology Engineer II in Monrovia, California, on a full-time basis. The role supports the manufacture of STAAR products through hands-on manufacturing support, process improvement, validation work and design transfer.

Key responsibilities

• Troubleshoot and resolve day-to-day manufacturing issues.
• Identify, source and pilot new equipment to support process improvements.
• Create and run validation protocols (IQ, OQ, PQ) and summarize test results.
• Run Test Method Validations (TMV) on measurement equipment.
• Optimize process flow, remove non-value-added steps and shorten lead time to Finished Goods Inventory.
• Support and lead design transfer for new products entering production.
• Conduct root cause analysis for production issues and support non-conforming material reports and CAPAs.
• Liaise with partners to drive continuous improvement and lead facility update projects.
• Review and approve process and engineering documents on behalf of Operations.

Required profile

• Bachelor's degree in a technical discipline or equivalent education/experience; master's degree a plus.
• Lean/Six Sigma or similar training a plus.
• Minimum of 5 years of experience in a regulated industry.
• Design transfer experience preferred; clean room operations experience a strong plus.

Required skills

• Practical understanding and implementation of cGMP/QSR/ISO requirements.
• Well versed in lean manufacturing and process improvement.
• Working knowledge of requirements around IOLs or other Class III medical devices.
• Ability to lead cross-functional teams to project plans and strong prioritization and organizational skills.