Job Description

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.



Ensure mechanical simulations, including structural, dynamic, and tolerance analyses, are effectively planned, executed, and reviewed to verify integrity and mitigate early-stage risks.



Lead investigation and resolution of mechanical and system-interface failures, ensuring timely root-cause analysis and corrective actions.



Collaborate with suppliers, OEMs, and manufacturing partners to enable reliable, scalable, and timely production.



Define and implement manufacturing enablers such as fixtures, automation, and inspection systems to ensure consistency, quality, and cost efficiency.



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.



Key Requirements



Bachelor's or Master's degree in Mechanical Engineering or a related field, with at least 12 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.



Other Information

Job Location:

Bangalore

Contact Mail Id:

career@bigtec.co.in , hr@bigtec.co.in