Mechanical Engineer – Medical Device Development

Mechanical Engineer – Medical Device Development

About the Opportunity

We are supporting an innovative, research-driven biopharmaceutical organisation developing next-generation drug delivery technologies designed to improve the delivery of medicines to the lungs.

As part of the continued development of an innovative Soft Mist Inhalation (SMI) device, we are looking for a Mechanical Engineer to join the Device Development team in Diepenbeek.

This is an excellent opportunity for a hands-on mechanical engineer with experience developing safety-critical or highly regulated products, who enjoys working from first principles and taking designs through development, verification and industrialisation.

You will work closely with the Chief Engineer and wider cross-functional teams, supporting the design and development of complex medical devices and associated manufacturing processes.

The Role

You will be responsible for supporting the mechanical design and development of medical devices, ensuring that products meet the required levels of quality, safety, performance and manufacturability.

Key responsibilities will include:

• Supporting the design, development and verification of medical devices
• Applying robust Design Control processes in accordance with relevant standards and procedures
• Developing and maintaining design inputs, outputs and technical documentation
• Leading CAD and product data management activities, including drawings, BOMs and configuration/version control
• Managing proof-of-concept activities using analytical modelling, calculations and empirical testing
• Assessing component and assembly designs against manufacturing capability, quality and cost requirements
• Applying DFMEA, risk management and structured problem-solving techniques
• Developing and reviewing design requirements and technical specifications
• Supporting Design for Manufacture (DFM) and the transition of products towards industrialisation
• Working with manufacturing partners to ensure designs can be produced to the required quality and cost
• Producing high-quality technical reports, presentations and design documentation
• Providing technical troubleshooting and structured problem solving, including methodologies such as 8D
• Working with multidisciplinary and international teams throughout the product development lifecycle

Essential Experience

• Master's degree in Mechanical Engineering
• Significant experience in the design and development of safety-critical or highly regulated products
• Experience working within a robust product design/development process
• Good understanding of medical device standards and regulatory requirements
• Hands-on experience with Design Controls
• Strong experience with risk management and DFMEA
• Experience with Design for Manufacture (DFM)
• Understanding of the relationship between DFMEA and PFMEA
• Strong hands-on CAD/CAE experience
• Experience with tolerance stack analysis
• Experience working with materials used in complex mechanical products, ideally including medical-grade plastics, springs and elastomers
• Strong analytical and problem-solving capabilities
• Excellent written and spoken English

Technical Tools & Methodologies

• Creo
• PDM / product data management systems
• JMP or other statistical analysis tools
• ICH Quality by Design (QbD)
• Lean Six Sigma
• Systems engineering
• Structured problem-solving methodologies

Desirable Experience

• Experience developing respiratory or inhalation devices
• Experience with complex drug-delivery devices
• Knowledge of respiratory standards and regulatory requirements
• Six Sigma training
• Experience contributing to patent filing or patent management