Mechanical Engineering Manager

2 weeks ago

Bengaluru, India bigtec Private Limited Full time

Lead the Mechanical team in designing and developing advanced medical diagnostic devices. Drive innovation in mechanical systems while ensuring reliability, manufacturability, and compliance with medical device standards. Deliver robust solutions that integrate seamlessly with optical, microfluidic, electronic, and software subsystems Key Responsibilities - Lead product design and development from concept to validation and transfer to manufacturing, ensuring technical and process integrity. - Provide technical leadership in developing mechanical subsystems that integrate seamlessly with optics, microfluidics, electronics, and software to deliver robust, compact diagnostic devices. - Oversee the design of enclosures, mechanisms, thermal management solutions, and structural components optimized for medical device use. - Guide material and process selection to ensure biocompatibility, durability, and cost- effectiveness. - Ensure DFX principles are embedded throughout design and development to enhance manufacturability, assembly, serviceability, and scalability. - Lead investigation and resolution of mechanical and system-interface failures, ensuring timely root-cause analysis and corrective actions. - Drive reliability and environmental stress testing to generate verification data for product qualification. - Establish and maintain mechanical design standards, best practices, and reusable design frameworks. - Lead design reviews, risk analyses, and verification plans with cross-functional teams. - Ensure adherence to ISO 13485, ISO 14971, and related standards during design and verification. - Supervise creation and maintenance of technical and regulatory documentation, including DHF, DMR, and risk files, ensuring audit readiness and compliance. - Manage effective use of facilities, equipment, and tools to enable domain-level rapid prototyping and capability enhancement. Qualifications & Experience - Bachelor’s or Master’s degree in Mechanical Engineering or a related field, with at least 10 years of experience in product design and development for medical or other safety-critical devices. - Proven expertise in mechanical design of enclosures, mechanisms, and structural components, with proficiency in CAD modeling, tolerance analysis, and DFM/DFA principles. - Experience in materials selection, mechanical simulations, and reliability testing(vibration, drop, thermal) to ensure manufacturability and durability. - Strong understanding of design controls, process validation (IQ/OQ/PQ), and regulatory documentation (DHF, DMR, risk management files). - Knowledge of applicable standards including ISO 13485, ISO 14971, ISO 10993 and IEC 60601.

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