praveen selvam

With over 16 years of experience, currently working as a Project Manager at DePuy Synthes, contributing to the design, development, and launch of innovative medical devices. Focused on enhancing product portfolios, adhering to regulatory compliance, and driving cross-functional collaboration to meet clinical specifications and industry standards. 

Expertise includes program management, mechanical testing, process risk assessment, and lifecycle management of spinal implants. Committed to improving patient outcomes by ensuring precision in product testing and mitigating manufacturing risks through robust protocols and teamwork. Passionate about delivering impactful healthcare solutions through advanced engineering practices.

• Led end-to-end regulatory strategy and execution for 52+ China NMPA license submissions, coordinating with local regulatory representatives, local type testing labs, and translators to ensure complete and compliant dossiers—including Product Technical Requirements (PTR) and conformity test protocols. Mitigated delays by harmonizing internal specifications, proactively resolving type testing failures, and addressing NMPA deficiency letters to enable successful approvals under GB/T and YY standards.
• End-to-End development and launch of Spine Posterior Thoracic-to-Sacral Fixation System for segmental stabilization, leveraging implants and instrumentation for robust surgical outcomes. Provided surgeons with an innovative intraoperative bailout screw solution, improving the revision of existing constructs and enhancing patient care in complex procedures.
• Introduced Bluetooth tracking devices into field equipment and loaner case sets for real-time location visibility, enabling seamless tracking by supply chain (SC) teams via mobile apps or hospital-installed readers. Devices were designed to be sterilized alongside the surgical sets, ensuring compliance with reprocessing protocols and maintaining system integrity.
• Product Risk Management, Developed and led risk assessment automated frameworks that reduced potential resource effort by 32%, employing quantitative risk analysis techniques.
• Planned and executed over 260 Process Risk Assessments (PRAs) in collaboration with manufacturing, quality, and regulatory teams, leveraging risk matrices to implement controls, reducing audit findings, and improved long-term process reliability.

Bachelors in mechanical engineering