Process Engineer

As a Process Engineer at ViCentra, 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.

Location:

Utrecht. Hybrid or on‑site.

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

Qualifications

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

Master’s degree in a relevant field (preferred)

Six Sigma certification (Green Belt or higher) (preferred)

Experience in medical device manufacturing, automation, and equipment lifecycle management (preferred)

Proficiency with tools such as Minitab and MS Project (preferred)

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