Process Development Engineer

Location: Bilthoven

Process Development Engineer
Kuros Biosciences is a Swiss-listed life science company with offices in Bilthoven, Atlanta, and Schlieren. The company focuses on orthobiologics for spinal fusion surgery.

Position Overview
As a Process Development Engineer, you will be responsible for designing, developing, and optimizing manufacturing processes for medical devices, ensuring compliance with quality and regulatory standards such as ISO 13485. You will play a critical role in implementing new products, scaling up new and existing processes and equipment, improving process efficiency, and ensuring consistent product quality.

Develop, validate, and implement robust manufacturing processes for existing and new products

Collaborate with R&D, Quality, and Manufacturing teams during product and process development for transfer to production

Design process layouts, work instructions, test protocols, and validation documentation (IQ/OQ/PQ)

Perform process capability studies and root cause analysis for process failures or deviations

Lead or participate in continuous improvement initiatives (Lean, Six Sigma, Kaizen, etc.)

Select, specify, and qualify production equipment, tooling, and automation systems

Ensure compliance with GMP, ISO 13485, and other relevant standards and regulations

Support regulatory submissions with process validation data and technical justifications

Provide technical support for troubleshooting and resolving manufacturing issues

Maintain clear and accurate documentation and reports

Skills

Able to work well independently and cooperatively in a cross‑functional team

Excellent interpersonal and people‑leadership skills

Good knowledge of English language required

Excellent communication skills to collaborate with cross‑functional team, internal and external parties, present findings, and document processes

Strong analytical and problem‑solving skills

Effective project planning, execution, and tracking to meet deadlines and budgets

Continuous improvement experience and project management skills; ability to design and improve manufacturing processes

The ability to think creatively and devise innovative solutions

Collaborating effectively with colleagues including operators, technicians, and other engineers

Comfortable working in a fast‑paced, regulated environment

Education and/or Experience

HBO (BSc) / University (MSc) in Biomedical Engineering, Medical Biology, or a related field

5+ years of experience in process development or manufacturing engineering, preferably in the medical device or pharmaceutical industry

Experience with IQ/OQ/PQ protocols and process validation

Previous experience working in a GMP environment and/or ISO 13485 preferred

What We Offer

A dynamic role with room for growth and impact

Opportunities to innovate and shape processes

A supportive, collaborative work environment

Professional development and learning opportunities

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