Mechanical Engineer – Medical Device Development
All potential applicants are encouraged to scroll through and read the complete job description before applying.
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 xqknzec 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
Mechanical Engineer – Medical Device Development • Diepenbeek, Limburg, BE
Luminex Network Intelligence is looking for a Senior Mechanical Design Engineer with strong expertise in sheet metal housings to design and develop robust enclosures for our electronic products.Is ... Laat meer zien
SII Belgium is seeking a highly motivated Hardware Engineers to join our team.In this role, you will be responsible for hardware debugging, analysis, and redesign of PCB systems, mostly within the ... Laat meer zien
Functie Als mechanical design engineer transformeer je de specifieke wensen van de klant naar een effectief mechanisch ontwerp.If you would like to know a bit more about this opportunity, or are co... Laat meer zien
We are looking for an IVVQ Engineer to lead system integration, verification, validation, and qualification activities across innovative, high-impact projects.In this role, you will oversee the ful... Laat meer zien
Möbius is een adviesbureau dat organisaties in verschillende sectoren helpt bij het ontwerpen en implementeren van de beste oplossingen.Onze +140 collega's zijn actief in België en Nederland en beg... Laat meer zien
We're partnered with a fast-growing technology company in the renewable energy sector searching for a.Software Engineer with strong Symfony experience.This organisation's product combines software ... Laat meer zien
Build AI that actually goes live, not just demos Are you a Medior AI Engineer ready to move beyond experiments and start delivering real-world AI solutions? At LACO, you’ll work on production-gra... Laat meer zien
The job location can be Leuven or Ghent.Scope The Product Engineer is responsible for ASIC products from product development kick-off until end of life.The Product Engineer will be responsible for... Laat meer zien
Je combineert technische expertise met een sterke projectmatige aanpak en zorgt ervoor dat projecten succesvol worden gerealiseerd binnen de vooropgestelde timing, kwaliteit en budget.Je bent de sp... Laat meer zien
Make sure to apply with all the requested information, as laid out in the job overview below.Provide technical support in Belgium.Deliver training for distributors and installers on product usage.R... Laat meer zien
De URGO Groep is specialist in wondzorg en verantwoorde gezondheidszorg.Als familiebedrijf, opgericht in 1880, zet de groep zich dagelijks in voor patiënten, zorgprofessionals en het brede publiek.... Laat meer zien
BlueFil® delivers high-performance separation solutions for mist elimination and emission control, helping industrial clients protect both their processes and the environment.The company serves par... Laat meer zien
Daarnaast geloven wij dat je als consultant nooit bent uitgeleerd en daarom krijg je bij ons de mogelijkheid om je zowel persoonlijk als vakinhoudelijk verder te ontwikkelen.Binnen onze ALTEN Acade... Laat meer zien
Bij Evolane is het onze missie om bedrijfsapplicaties te optimaliseren, organisaties te ontzorgen en eindgebruikers de beste user experience te bieden.Een aanpak op maat zorgt ervoor dat elk van on... Laat meer zien
Beschrijving van de functie About this job Krijg jij een kick van defecten opsporen en technische problemen oplossen? Ben jij analytisch ingesteld en wil je graag werken met de nieuwste diagnoseapp... Laat meer zien
The Key Account Manager (KAM) is a field based position focused on selling Diagnostic Imaging products into hospitals, imaging centres, radiation oncology, etc.KAM is the primary owner of assigned ... Laat meer zien
GWE is looking for a Business Developer with technical background for (West) Africa to expand our global sales force and contribute to GWE’s business development.This is a challenging position for ... Laat meer zien
Als Sales Engineer ben je het aanspreekpunt voor klanten in de regio Antwerpen en Limburg.Je begrijpt hun behoeften en biedt op maat gemaakte HVAC-oplossingen aan.Je werkt flexibel vanuit de markt,... Laat meer zien
Ben jij iemand die graag impact maakt op de werkvloer in een high-tech productieomgeving? Wil je meewerken aan hoe geneesmiddelen veilig en kwaliteitsvol geproduceerd worden? Voor een toonaangeven... Laat meer zien
Voor onze klant, een familiebedrijf en gespecialiseerde speler binnen industriële smeermiddelen en technische oplossingen, zijn wij op zoek naar een Sales Engineer Industrie met een sterke commerci... Laat meer zien
