A Medical Devices Architect Job

2 days ago

Kozhikode, Kerala, India beBeeDesign Full time ₹ 35,00,000 - ₹ 50,00,000

Be a part of pioneering advancements in medical devices by joining our team as a Medical Devices Design Architect. As a visionary Design Engineer, you will drive the development of innovative technologies to tackle complex healthcare challenges.

This pivotal role requires your expertise in design calculations, GD & T and tolerance stack up analysis. Your skills in CAD software (e.g., SolidWorks, CreO, AutoCAD) and FEA simulation tools (e.g. ANSYS, COMSOL) will be instrumental in crafting and optimizing devices that uphold the highest standards of performance, safety, and regulatory compliance.

You will lead the conceptualization, design, development, and optimization of mechanical systems and sub-systems for medical devices from concept to production. Key responsibilities include designing new products or components to meet specific performance, aesthetic, and functional requirements.

Your tasks will involve creating 3D models and detailed drawings using CAD software, conducting engineering analyses, including stress, thermal, and fluid dynamics simulations, to optimize mechanical designs and ensure proper function. You will also select appropriate materials based on factors like mechanical properties, thermal stability, biocompatibility, durability, sterilization compatibility, and cost-effectiveness.

Additionally, you will develop and optimize products in sheet-metal, machining and plastic processing techniques (e.g. injection molding, extrusion, blow molding, thermoforming, and other plastic processing techniques). Staying up-to-date with the latest advancements in materials science, plastic technologies, and manufacturing processes is essential for this role.

Conducting rigorous testing and validation of designed systems to ensure functionality, performance, and compliance with relevant medical device standards (e.g., FDA, EUMDR, CDSCO, ISO 13485) is crucial. Creating and maintaining accurate and comprehensive documentation of designs, specifications that includes interface design and specifications, test procedures, and verification reports for medical devices is also a key responsibility.

To excel in this role, you should possess a Bachelor's or Master's degree in Mechanical Engineering from a reputed Institute. A minimum of 8-12 years of prior experience in MEDICAL DEVICE design and development, with a strong understanding of regulatory requirements and standards, is also required.

Skill requirements include:

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