Mechanical Design Engineer (Insulin Delivery Systems)

Role & responsibilities

• Lead end-to-end design and industrialisation of disposable drug reservoirs, infusion sets and fluidpath components for wearable delivery devices.
• Create concept and detailed CAD, drawings and tolerance stacks optimised for highvolume injection moulding and automated assembly; drive DfM/DfA with suppliers.
• Prototype rapidly and validate to requirements (leak/occlusion/burst, flow resistance, particulate, usability) with documented V&V.
• Select materials and joining methods (medicalgrade polymers, adhesives, cannulas, membranes) aligned with ISO 10993, ISO 80369 and ISO 11607; consider sterilisation (EtO/gamma) and package validation.
• Own DHF artefacts and risk analysis (ISO 14971); support process validation (IQ/OQ/PQ), FAI/PPAP and production ramp.
• Identify and onboard manufacturers; qualify moulds/tooling, agree process windows and inspection plans; monitor cost, yield and reliability.
• Feed postmarket learnings into design updates to improve robustness and cost.

Preferred candidate profile

• Bachelor's/Masters in Mechanical Engineering, Polymer Science or related field.
• 4+ years of experience with Mandatory prior experience in delivering medical consumables (reservoirs/tubing/catheters or analogous devices) from concept to mass production.
• Proficiency in SolidWorks (required), GD&T, tolerance analysis; exposure to Moldflow/CAE is a plus.
• Strong grasp of fluid handling, sealing and failure mode prevention for small volume drug delivery; familiarity with sterilisation and shelf-life considerations.
• Working knowledge of ISO 13485, ISO 80369, ISO 10993, ISO 11607 and ISO 8536 where applicable.
• Clear, complete documentation and effective supplier collaboration.

Startup Environment