Manufacturing Engineer

Manufacturing & Design Transfer Engineer

Introduction

Our client is developing, producing, and marketing an innovative and sustainable technology for use in the cardiac surgery setting, focused on improved temperature control and disinfection. Their next-generation Heater-Cooler System is designed to offer hospitals a safer, cleaner, and more reliable alternative to traditional devices.

As the company scales up production and prepares for wider international market adoption, they are strengthening the engineering organisation with hands-on technical expertise to ensure robust manufacturing, mature industrialisation processes, and a smooth transfer from design into stable, scalable production.

As Manufacturing & Design Transfer Engineer , you play a key role in translating product designs into efficient, reliable, and cost‑effective production. You work closely with R&D, RAQA, and Manufacturing to ensure that product updates and new developments can be produced consistently and in compliance with medical device requirements.

Key Responsibilities:

Design Transfer & Industrialisation

• Lead the transfer of new and updated designs from R&D into production.
• Ensure manufacturability, documentation readiness, and smooth integration into existing production processes.
• Oversee NPI activities, including pilot build and preparation for scale-up.
• Contribute to design optimisation aimed at lowering cost price, improving reliability, and simplifying production.

Manufacturing Engineering

• Develop and improve manufacturing processes with a strong focus on practicality, efficiency, and scalability.
• Manage production and engineering activities to improve product quality, testability, and yield.
• Manage continuous improvement and problem‑solving in manufacturing processes.
• Ensure compliance with medical device regulations during production ramp‑up.
• Maintain close contact with manufacturers and suppliers to align on feasibility, cost structure, and process requirements.
• Lead internal production initiatives, including the potential insourcing of components (e.g., tubing sets), and oversee the preparation of the associated facilities to ensure readiness and efficiency.

Daily Engineering Activities

• Serve as the primary technical point of contact, with a solid grasp of system behaviour, critical subsystems, and their implications for production.
• Ensure alignment with regulatory and quality requirements in collaboration with RAQA.
• Provide hands-on engineering support for troubleshooting, design refinement, and process issues.
• Monitor cost price development and identify cost‑reduction opportunities.

Profile

• Bachelor’s or master’s degree in mechanical, Electrical, Biomedical, or Industrial Engineering.
• Strong experience (7+ years) in manufacturing engineering, industrialisation, or medical device product development.
• Hands-on, practical mindset with experience in translating design concepts into efficient manufacturing processes.
• Experience in Design for Manufacturing (DFM), supplier interaction, and cost engineering.
• Affinity (not primary responsibility) with V&V activities; ability to collaborate with the V&V function where needed.
• Structured, communicative, and comfortable working cross‑functionally.

Team

This role sits within a small, highly innovative scale-up environment where the team works hands-on and collaboratively across disciplines. Because of the organisation’s size and rapid growth, the role is deliberately broad and offers substantial opportunities to learn, contribute, and develop new skills.

Please contact Bart Heerdink via if you'd like to know more.