Principal Mechanical Architect

About the Role:

We are seeking a visionary Mechanical Architect to lead the development of innovative technologies that tackle complex healthcare challenges. As a key member of our cross-functional team, you will work closely with our leadership team that brings over 100 years of collective experience and collaborates with India's premier research institutes.

As a Mechanical Architect in the medical device domain, your design engineering expertise will be pivotal in crafting and optimizing devices that uphold the highest standards of performance, safety, and regulatory compliance.

Key Responsibilities:

• Conceptualize, Design, Develop, and Optimize Mechanical Systems: You will be responsible for designing, developing, and testing advanced mechanical systems for next-generation medical devices from concept to production.
• Design New Products or Components: You will design new products or components to meet specific performance, aesthetic, and functional requirements.
• Create 3D Models and Detailed Drawings: You will create 3D models and detailed drawings using CAD software like SolidWorks / CreO.
• Conduct Engineering Analyses: You will conduct engineering analyses, including stress, thermal, and fluid dynamics simulations, to optimize mechanical designs and ensure proper function.
• Select Materials: You will select appropriate materials based on factors like mechanical properties, thermal stability, biocompatibility, durability, sterilization compatibility, and cost-effectiveness.
• Develop and Optimize Products: 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 Industry Advancements: You will stay up to date with the latest advancements in materials science, plastic technologies, and manufacturing processes.
• Testing and Validation: You will conduct 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).
• Documentation and Communication: You will create and maintain accurate and comprehensive documentation of designs, specifications, test procedures, and verification reports for medical devices. Prepare progress reports, technical presentations, and updates for project stakeholders, regulatory submissions, and audits.
• Regulatory Compliance: You will ensure that all design and development activities adhere to relevant medical device regulations and standards.
• Continuous Learning and Development: You will contribute to the development of new and innovative medical device technologies and participate in continuous learning and development within the field of medical devices.

Required Skills and Qualifications:

• Bachelor's or Master's Degree in Mechanical Engineering: You should possess a Bachelor's or Master's degree in Mechanical Engineering from a reputed Institute.
• Prior Experience in Medical Device Design and Development: You should have minimum 8-12 years of prior experience in MEDICAL DEVICE design and development, with a strong understanding of regulatory requirements and standards.
• Design Calculations, GD & T, and Tolerance Stack Up Analysis: You should have strong skills in design calculations, GD & T, and tolerance stack up analysis.
• CAD Software and FEA Simulation Tools: You should have expertise in CAD software (e.g., SolidWorks, CreO, AutoCAD) and FEA simulation tools (e.g., ANSYS, COMSOL).
• Materials Selection and Manufacturing Processes: You should have experience with materials selection for medical devices, biocompatibility testing, and manufacturing processes for medical devices.
• Medical Device Regulations and Standards: You should have an in-depth understanding of medical device regulations, standards, and certification processes, familiarity with FDA regulations (e.g., 21 CFR Part 820), ISO 13485 standards, CE marking requirements, and applicable international standards (e.g., IEC 60601).
• Analytical and Problem-Solving Abilities: You should have strong analytical and problem-solving abilities to tackle complex design challenges.
• Interpersonal and Communication Skills: You should have excellent interpersonal and communication skills to collaborate effectively with cross-functional teams.
• Meticulous Approach to Design and Documentation: You should have a meticulous approach to design and documentation to ensure precision and regulatory compliance.