Manufacturing Science & Technology Engineer II: Process & Validation

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

Job summary

STAAR Surgical in Monrovia, CA is seeking an experienced manufacturing professional to support the production of STAAR products. You will troubleshoot day-to-day manufacturing issues, source and pilot new equipment, and create validation protocols for IQ/OQ/PQ and TMV on measurement equipment.

You will optimize process flow, lead design transfer for new products, perform root-cause analyses, and support CAPAs to drive continuous manufacturing improvements.

Qualifications

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

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 in product handling; increase efficiencies; and reduce product 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 in order 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

Team leadership

Prioritization

Cross-functional leadership

Lean manufacturing

IOL/Class III knowledge

Education

Bachelor's in technical discipline

Master's in technical discipline

Lean/Six Sigma training

Job description

STAAR Surgical in Monrovia, CA is seeking an experienced manufacturing professional to support the production of STAAR products. You will troubleshoot day-to-day manufacturing issues, source and pilot new equipment, and create validation protocols for IQ/OQ/PQ and TMV on measurement equipment.

You will optimize process flow, lead design transfer for new products, perform root-cause analyses, and support CAPAs to drive continuous manufacturing improvements.