Manufacturing Science &Technology Engineer II

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

MAIN JOB RESPONSIBILITIES / COMPETENCIES

In support of the manufacture of STAAR products:

• 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.

REQUIREMENTS

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
• Design experience using CAD or related software 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

Pay range: $85-$110k 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.

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