Senior Mechanical Engineer - Medical Devices

About the role

Hlx Life Sciences is recruiting, on behalf of an international medical technology company, experienced mechanical design engineers. You will join a multidisciplinary R&D team and take products from early concept through design transfer into series production in a fully regulated environment.

Key responsibilities

• Own the mechanical design of Class II and III medical devices and subassemblies such as drug delivery systems, surgical instruments, implantable components and electromechanical diagnostic platforms
• Build detailed 3D CAD models and 2D production drawings in SolidWorks, Creo or Siemens NX, applying GD&T to ASME Y14.5 / ISO GPS
• Perform tolerance stack-up analyses (worst-case and statistical/RSS) and run FEA for structural and thermal verification
• Design precision plastic and metal parts for manufacturing (injection moulding, CNC machining, MIM, sheet metal, additive manufacturing) and select materials for biocompatibility, sterilisation and chemical resistance
• Run design control activities to ISO 13485 and FDA QMSR (21 CFR 820) and contribute to ISO 14971 risk management (dFMEA, pFMEA)
• Plan and execute design verification and validation, and support usability engineering to IEC 62366-1 and electrical safety to IEC 60601-1
• Build and test prototypes, work with suppliers and contract manufacturers on tooling and FAI, and lead design transfer to manufacturing
• Contribute to technical documentation for EU MDR and FDA 510(k) / PMA submissions

Required profile

• Master's or Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Micro-Engineering or a related field
• 5+ years of mechanical design experience in medical devices (highly regulated industries such as aerospace or automotive also considered)
• Structured, documentation-focused approach with strong problem-solving skills
• Fluent business English; German and/or French are a strong plus

Required skills

• Expert CAD skills (SolidWorks, Creo or NX) and PDM/PLM systems (Windchill, Teamcenter, Agile)
• GD&T, tolerance analysis and design for injection-moulded parts
• Solid working knowledge of ISO 13485, ISO 14971 and design control
• Nice to have: CETOL, 3DCS, ANSYS, Abaqus, IEC 60601, IEC 62366, ISO 11608, drug-device combination products, Design for Six Sigma or Lean