Process Engineer

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

Join ViCentra – Empower Bold Change in MedTech

Location: Utrecht

Hybrid or On-site

At ViCentra, we’re on a mission to make living with diabetes easier, by designing simple, beautiful, and effective solutions that fit people’s lives, not the other way around. We combine technological innovation with human-centered design to empower people with more freedom, confidence, and life on their terms. Our values; Be Bold, Build Trust, Focus on the Customer and Deliver Excellence drive everything we create and every decision we make.

At ViCentra, we’re on a mission to make living with diabetes easier, by designing simple, beautiful, and effective solutions that fit people’s lives, not the other way around. We combine technological innovation with human-centered design to empower people with more freedom, confidence, and life on their terms. Our values; Be Bold, Build Trust, Focus on the Customer and Deliver Excellence drive everything we create and every decision we make.

We believe that when ambition meets purpose, remarkable things happen. If you thrive in a space where ideas accelerate, challenges spark growth, and making a difference is the goal, ViCentra is your next great adventure.

Your Impact

As a Process Engineer, you will sit at the core of how our products are built, scaled, and continuously improved. You will take ownership of critical manufacturing processes, ensuring they are robust, efficient, and fully compliant with medical device regulations. In this role, your work will directly influence the quality of our products and the speed at which we can bring innovation to the people who rely on them. By applying a continuous improvement mindset and leveraging data-driven insights, you will drive meaningful enhancements in performance, cost, and reliability across our production operations. Working closely with Engineering, Quality, Operations, and R&D, you will act as a key technical partner in introducing new technologies and scaling manufacturing capabilities. Your ability to connect process design, equipment, and regulatory requirements will ensure that every solution we deliver is not only innovative, but also manufacturable at the highest standard. Ultimately, your contribution will go beyond improving processes, it will help ensure that our life-changing devices reach people with the consistency, quality, and reliability they depend on.

What You’ll Take On

• 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

What You Bring

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

Desired

• Master’s degree in a relevant field
• Six Sigma certification (Green Belt or higher)
• Experience in medical device manufacturing, automation, and equipment lifecycle management
• Proficiency with tools such as Minitab and MS Project

Life at ViCentra

• Courage to create: We experiment, challenge norms, and learn fast.
• Trust above all: Integrity, honesty, and openness shape our relationships.
• Customer-first mindset: Every idea is measured by the impact on those we serve.
• A drive for excellence: We hold ourselves to the highest standard because lives depend on it.

Our days move fast, fueled by curiosity, diverse perspectives, and a love for collaboration. Here, you can shape and be shaped by groundbreaking work in MedTech.

Grow With Purpose

• Harness your talent for a mission that truly matters.
• Enjoy creative freedom, supportive teamwork, and room to lead initiatives.
• Make a direct impact in people’s lives, today and into the future.
• Be surrounded by innovators who challenge and cheer you on.

We believe a powerful team is built on unique backgrounds and points of view. If this opportunity excites you but you’re unsure if you fit every bullet, we want to hear your story. At ViCentra, it’s your potential and passion that catch our eye.