Manufacturing Science &Technology Engineer II

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 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

• 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 of 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

$85,000–$110,000 per year, depending on experience.