Senior Mechanical Engineer

About the role

We are recruiting a Senior Mechanical Engineer to support the Chief Engineer in the design and development of the SMI medical device and related products. The role requires strict adherence to Design Control under ISO13485, the use of robust design tools, and the ability to industrialise the product for manufacturing.

Key responsibilities

• Provide expertise in medical device design to ensure successful design, development, and verification of invoX devices.
• Establish and maintain design controls in line with SOPs and relevant regulatory guidelines.
• Lead the use of CAD and PDM software, ensuring compliance with drawing standards, versioning, and release control.
• Manage proof‑of‑concept activities through analytical modelling and empirical testing.
• Assess design intent of components and assemblies against manufacturing capability, quality, and cost targets.

Required profile

• Master’s degree in Mechanical Engineering.
• Strong understanding of medical device standards and essential requirements.
• Hands‑on experience with design control, risk management (DFMEA) and design for manufacture.
• Proficiency with CAD/CAE tools (Creo preferred), tolerance analysis and statistical tools (JMP preferred).
• Excellent problem‑solving abilities and capacity to work autonomously.

Required skills

• CAD/CAE (Creo)
• Tolerance stack analysis
• Statistical analysis (JMP)
• Design control (ISO13485)
• Risk management (DFMEA)
• Materials expertise (medical grade plastics, springs, elastomers)