02 Oct
|
Biotech Healthcare
|
Ahmedabad
02 Oct
Biotech Healthcare
Ahmedabad
Role Objective:
A key objective of this role is to lead the end-to-end R&D; strategy, product-development roadmap and technical execution for the organization's IOL portfolio, ophthalmic implantable devices and ophthalmic surgical items.
The role is responsible for providing technical leadership in optical design, IOL power calculation, recent-product development, design controls, regulatory compliance, clinical and technology evaluation, product commercialization, and continuous improvement.
Desired Candidate Profile
Education
Minimum:
B.E./B.Tech, M.Tech, M.S. or Ph.D. in:
• Optics / Optical Engineering
• Biomedical Engineering
Desirable:
• Advanced specialization in Optical Engineering, Biomedical Engineering or ophthalmic medical-device development.
Experience Requirement
Minimum:
• 10+ years of progressive R&D; experience in the ophthalmic / medical-device industry.
• Significant hands-on and leadership experience in IOLs, ophthalmic implantable devices and/or ophthalmic surgical items.
• Experience managing product development from concept through commercialization in a regulated environment.
Desirable:
• Experience leading multidisciplinary R&D; teams.
• Exposure to working with international customers and Quality Agreements.
• Experience in technology transfer, licensing and external innovation partnerships.
Role Requirements
• Strong working knowledge of ISO 13485, 21 CFR Part 820, ISO 11979 series and ISO 14971, with hands-on experience in design controls, risk management and Design History Files.
• Deep understanding of optical design and IOL power calculation methodology, with proficiency in Zemax or equivalent optical-design software.
• Experience in domestic and international product registrations and regulatory audits.
• Exposure to PMCF, clinical studies, product-performance analysis and competitor benchmarking.
Role & Responsibilities
• Own the end-to-end R&D; strategy and roadmap for the organization’s IOL portfolio, ophthalmic implantable devices
📌 General Manager – R&D (Ahmedabad)
🏢 Biotech Healthcare
📍 Ahmedabad