Manufacturing Process Improvement & Design Transfer Engineer

STAAR Surgical Company; Monrovia (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

STAAR Surgical is seeking a manufacturing process engineer to support the manufacture of STAAR products. You will troubleshoot day-to-day issues, identify and pilot new equipment for process improvements, and create/execute validation and TMV protocols to ensure measurement accuracy.

You will optimize flow, lead design transfer for new products, perform root cause analysis, and support CAPAs and non-conforming material actions. Strong CAD experience is preferred.

Qualifications

• Bachelor’s degree in a 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
• Minimum of 5 years experience in a regulated industry
• Design transfer experience preferred
• Clean room operations experience a strong plus
• Design experience using CAD or related software preferred.

Responsibilities

• Provide assistance in troubleshooting/resolving day to day manufacturing issues
• Identify, source, and pilot new equipment to support process improvements in manufacturing
• Create and execute validation protocols (IQ, OQ, PQ) and summarize test results as required
• Create and execute Test Method Validations (TMV) on measurement equipment
• Optimize process flow and eliminate non-value added steps to reduce lead time to Finished Goods Inventory
• Support and lead manufacturing design transfer activities for new products being introduced to production
• Conduct root cause analysis for issues found in production
• Support open non-conforming material reports and CAPAs
• Liaise with relevant partners to drive continuous improvements in manufacturing
• Lead facilities update projects to support manufacturing
• Review and approve process and engineering documents on behalf of Operations
• Other duties as assigned.

Skills

cGMP/QSR/ISO knowledge

Team leadership

Cross-functional collaboration

Lean manufacturing

Prioritization & multitasking

Design transfer

Project execution

Education

Bachelor’s degree in technical discipline

Master’s degree in a technical discipline

Lean/Six Sigma training

Tools

CAD software

Job description

STAAR Surgical is seeking a manufacturing process engineer to support the manufacture of STAAR products. You will troubleshoot day-to-day issues, identify and pilot new equipment for process improvements, and create/execute validation and TMV protocols to ensure measurement accuracy.

You will optimize flow, lead design transfer for new products, perform root cause analysis, and support CAPAs and non-conforming material actions. Strong CAD experience is preferred.