Job Description & Skill Requirement:
Key Responsibilities:
• Design & Development: Design, model, and prototype precision mechanical components, optical mounts, and housings for ophthalmic instruments using 3D CAD software (SolidWorks/Creo).
• Opto-Mechanical Engineering: Perform opto-mechanical design tasks, including lens barrel design, lens mounting techniques, and tolerance studies to maintain optical alignment.
• Analysis & Simulation: Conduct Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) to analyse stress, thermal behaviour, and vibration, ensuring device reliability.
• Documentation & Compliance: Create, maintain, and manage technical documentation (specifications, drawings, BOMs) and ensure compliance with FDA 21 CFR 820.30 and ISO 13485 standards.
• Prototyping & Testing: Support prototype builds, design iterations, and validation testing to meet performance, safety, and regulatory requirements.
• DFM/DFA: Collaborate with manufacturing teams to optimize designs for manufacturability (DFM) and assembly (DFA), including injection molding, plastics, and precision machining.
• Risk Management: Participate in Failure Mode and Effects Analysis (DFMEA/FMEA) to minimize operational risks.
• Bachelor''s or master''s degree in mechanical engineering.
• Previous experience designing ophthalmic surgical tools or diagnostics.
• 10+ years of experience in mechanical design, preferably within the medical device or optical industry.
• Highly proficient in 3D CAD modelling software (e.g., SolidWorks, Creo).
• Hands-on experience with precision machining, injection molding, or small-part assembly.
• Strong understanding of geometric dimensioning and tolerancing (GD&T).
• Experience with PLM software
Qualification:
• B.E / M.S / Mtech
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