Lead Designer - Mechatronics

We are developing an affordable tubed insulin pump (Class C medical device under Indian MDR 2017). We need a lead designer who can own the electromechanical design of the device from the current prototype stage through design freeze, verification, and design transfer to manufacturing. This is a hands-on design leadership role, not a programme management role. You will be the primary technical owner of the pump's mechanical, electrical, and systems design.

Responsibilities:

• Own the mechanical and electrical design of the insulin pump from current prototype to design-freeze.
• Drive miniaturisation and form-factor optimisation for patient wearability.
• Collaborate with the QA/Regulatory lead to ensure design outputs meet verification requirements and standards compliance.
• Contribute to the Design History File (DHF) and design review process.
• Work with contract manufacturing partners on DFM, BOM finalisation, and design transfer.
• Support risk management activities (DFMEA, design-side hazard analysis) under ISO 14971

Requirements:

• Mechatronics / electromechanical engineering background with 5-7 years of experience in product design and development. Medical device or regulated electromechanical product experience strongly preferred.
• Full product lifecycle experience must have taken at least one product from concept through detailed design, prototyping, verification, and design transfer to manufacturing. Not just prototype-stage work.
• Proficiency in design tools: SolidWorks (3D CAD), MATLAB/Simulink (control systems and simulation), and thermal analysis tools (e. g., Pthermal, ANSYS Icepack, or equivalent).
• Working knowledge of medical device regulatory requirements, specifically ISO 13485 (QMS), ISO 14971 (risk management), and IEC 60601-1 (general safety for medical electrical equipment) as they apply to the design and development process. You don't need to be the regulatory expert, but you need to design with these standards in mind from day one.
• Technical documentation ability and experience writing and reviewing design specifications, technical reports, design history file (DHF) inputs, and engineering change documents.

Good to Have:

• Exposure to IEC 62304 (medical device software lifecycle) not as a software developer but as an understanding of how firmware/software interfaces with hardware design decisions and documentation requirements.
• Experience with Design for Manufacturing (DFM) and working directly with contract manufacturers on tooling, tolerancing, and production readiness.
• Experience with miniaturisation of electromechanical assemblies relevant to our form-factor goals.

Skills

MATLAB, Simulink, SolidWorks, electromechanical, mechatronics