Process Engineering

Position Overview

The Process Engineer leads process engineering projects and continuous improvement initiatives supporting the manufacturing of intraocular lenses in Groningen and across other sites using the same processes. The role requires strong technical expertise and project management skills to drive process improvements, characterization activities, and design or NPI changes while collaborating with cross‑functional teams. The engineer is responsible for problem identification, root cause analysis, project execution, reporting, financial analysis, support new product introduction and implementing productivity and efficiency improvements. Close collaboration with other departments, sites, and corporate functions is required to achieve quality, delivery, cost, and KPI objectives, all within GMP and ISO compliance.

Key Responsibilities
Responsible for providing technical leadership within a production value stream and have ownership for the following:

• Identify key opportunities to develop and implement equipment and/or process enhancements that will improve efficiency, product yield, and safety.
• Identify, plan, and implement projects related to product and process improvement, ensuring alignment with strategic goals.
• Design and implement experimental protocols applying statistical tools to enhance manufacturing processes and product performance.
• Analyze current processes to identify key opportunities for equipment and process enhancements that improve efficiency, yield, and safety.
• Develop detailed documentation for process validation, project management, business case proposals, and root cause problem solving while ensuring compliance with industry regulations and internal standards.
• Monitor and analyze production data to identify trends and provide actionable insights for continuous improvement.
• Lead Six Sigma initiatives to drive process optimization and problem resolution within production environments.
• Support NPI launch by completing process characterization work, process challenge testing, process capability and stability runs, to qualify new product & processes and achieve annual business plan.
• Engage with personnel in the identification and resolution of corrective/preventative actions that address any process quality related manufacturing issues.

Required Qualifications

• Bachelor’s degree in Engineering or Material Science with 4+ years of relevant experience, or a Master’s degree in Engineering with 2+ years of experience
• Project management experience in an engineering environment

Preferred Experience

• 2+ years of experience in an engineering role within an FDA‑regulated environment
• Six Sigma certification or extensive experience applying Six Sigma methodologies for analytical problem solving

Preferred Skills:

Analytical Reasoning, Computerized Equipment Skills, Corrective and Preventive Action (CAPA), Emerging Technologies, Execution Focus, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Process Control, Process Engineering, Process Oriented, Product Improvements, Project Engineering, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy