R&D Sr Engineer Process Engineering

AMO Groningen BV is specialized in the development, improvement and manufacturing of state of the art surgical ophthalmic products, mainly intraocular lenses. The facility consists of small and integrated Research, Development and Manufacturing teams that have strong track records.

We are searching for the best talent for R&D Sr. Engineer - Process Engineering.

Purpose: Driving activities related to the design and development of innovative intraocular lenses (IOLs) for the Research & Development team.

You will be responsible for:

• Analyze product and process requirements (materials, quality, EHS) and perform risk and root cause analysis.
• Develop and improve product designs, processes, equipment, test methods, and procedures; define technical requirements.
• Plan and execute validation and verification studies, including test plans, protocols, data analysis, and issue resolution.
• Implement new or modified products and processes, author SOPs, protocols, risk assessments, and train employees.
• Maintain compliance with cGMP, ISO standards; update procedures, support audits, and resolve CAPAs/NCRs.
• Collaborate with Operations, QA, and Manufacturing Engineering to support implementation and design transfer.
• Lead complex design analysis and verification testing.
• Lead small projects and mentor more junior engineers.
• Provide technical leadership for new product development and process optimization.
• Ensures manufacturing process readiness for new product introduction (NPI) projects and acts as technical leader for process development and design transfer activities.

Qualifications / Requirements:

• Bachelor’s degree in Engineering or related field with minimum 6 years of experience in a regulated industry.
• Master’s degree preferred with minimum 4 years of experience.
• Proficient in applying statistical methodologies and analysis using Minitab.
• Proficiency in English, ideally also in Dutch.

Preferred specific knowledge and skills:

• Experience in rapid prototyping techniques using 3D printing.
• Six Sigma Certified Green Belt / Black Belt.
• Knowledge in high precision machining (lathing and milling).
• Knowledge in high precision injection molding.

Required Skills:

Analytical Reasoning, Collaborating, Mentorship, Strategic Thinking, Validation Testing

Preferred Skills:

Agile Decision Making, Coaching, Critical Thinking, Emerging Technologies, Engineering, Problem Solving, Process Control, Process Engineering, Process Improvements, Product Costing, Product Improvements, Research and Development, SAP Product Lifecycle Management, Situational Awareness, Technical Research, Technical Writing, Technologically Savvy, Vendor Selection