Process Engineer - Medical Devices | Lean Six Sigma

ROM Utrecht Region; Utrecht; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

ViCentra B.V. is seeking a Process Engineer to own critical manufacturing processes in a high‑volume medical device setting. You will lead continuous improvement initiatives, design and qualify processes, and collaborate with QA and Regulatory teams to ensure ISO 13485 and GMP compliance.

Your work drives quality, cost efficiency, and fasterInnovation in our production operations. You will apply data-driven insights, plan validations, and develop supporting documentation while expertly managing

Qualifications

• Experience leading continuous improvement in manufacturing environments.
• Strong Lean/Six Sigma methodology application.
• Ability to design, optimise, qualify manufacturing processes and equipment.
• Proven project management with cross-functional teams.
• Analytical thinker with clear communication skills.
• Familiarity with ISO 13485 and GMP requirements.

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 with Quality Assurance and Regulatory teams to ensure compliance
• Ensure adherence to ISO 13485, GMP, and other relevant regulations
• Experience in a high-volume manufacturing environment
• Experience with ISO 13485 and/or GMP environments
• Strong project management skills and a track record of delivering manufacturing projects

Skills

Continuous improvement

Lean/Six Sigma

Manufacturing processes

Project management

Analytical skills

Communication skills

ISO 13485

GMP

Job description

ViCentra B.V. is seeking a Process Engineer to own critical manufacturing processes in a high‑volume medical device setting. You will lead continuous improvement initiatives, design and qualify processes, and collaborate with QA and Regulatory teams to ensure ISO 13485 and GMP compliance.

Your work drives quality, cost efficiency, and fasterInnovation in our production operations. You will apply data-driven insights, plan validations, and develop supporting documentation while expertly managing