Adiuvo Diagnostics Private Limited, an ISO 13485:2016 QMS company, is a leader in developing innovative medical devices. We are seeking a Regulatory Head to oversee end-to-end regulatory affairs, ensuring compliance with US FDA, EU MDR, and Indian CDSCO requirements.

Key Responsibilities:

Seeking an experienced Mechanical Design Engineer with a background in new product development (NPD) for consumer electronics or medical devices.

Key Responsibilities:

Lead NPD Projects – Manage electro-mechanical and opto-mechanical design projects, ensuring adherence to budgets and timelines.
CAD & Design Optimization – Proficient in Autodesk Fusion 360 and SolidWorks; optimize designs for manufacturability.
Technical Documentation – Develop detailed specifications, GD&T, and manufacturing drawings.
Simulation & Analysis – Use tools like Ansys for simulations, tolerance stack-up, and optical design analysis.
Manufacturability – Apply DFM/DFA principles; experience with additive manufacturing and 3D printing.
Material & Prototyping – Select materials and conduct prototyping/testing.
Compliance Standards – Familiar with ISO 13485 and relevant medical device standards.
Communication & Presentation – Strong technical communication and rendering skills.

Qualifications:

2-4+ years in mechanical design engineering, NPD focus
Strong understanding of mechanical principles and optical components

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Mechanical Engineer