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