MedTech Process Engineer: Lean, GMP, Impact

Kaleido; Utrecht; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

ViCentra seeks a Process Engineer to own critical manufacturing processes, drive continuous improvement, and ensure compliance with medical device regulations. You will collaborate with Engineering, Quality, Operations, and R&D to scale capabilities and deliver reliable, high-quality devices.

You will design and qualify processes, develop documentation, and lead validation activities to meet strict industry standards.

Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Biomedical, Industrial Engineering, or related field.
• Experience in a high-volume manufacturing environment.
• Experience with ISO 13485 and/or GMP environments.
• Strong analytical skills and experience with manufacturing data and statistics.
• Excellent communication skills in English.

Responsibilities

• Lead and execute continuous improvement initiatives, including root cause analysis and Lean/Six Sigma projects
• Design, develop, optimise, and qualify manufacturing processes, methods, and equipment
• Support the development and qualification of tools, fixtures, and manufacturing equipment
• Create and maintain manufacturing documentation such as work instructions and process specifications
• Plan and execute validation activities to ensure processes and equipment meet regulatory and company standards
• Identify and implement process improvements to enhance quality, reduce costs, and improve throughput
• Collaborate closely with Quality Assurance and Regulatory teams to ensure compliance
• Ensure adherence to ISO 13485, GMP, and other relevant regulations
• Work cross-functionally with Engineering, Operations, and R&D teams

Skills

Continuous improvement

Project management

Analytical skills

English communication

Manufacturing data

Education

Bachelor's in Mechanical/Manufacturing/Biomedical/Industrial Engineering

Tools

Minitab

MS Project

Job description

ViCentra seeks a Process Engineer to own critical manufacturing processes, drive continuous improvement, and ensure compliance with medical device regulations. You will collaborate with Engineering, Quality, Operations, and R&D to scale capabilities and deliver reliable, high-quality devices.

You will design and qualify processes, develop documentation, and lead validation activities to meet strict industry standards.