01 Oct
|
Biotech Healthcare
|
Gujarat
01 Oct
Biotech Healthcare
Gujarat
Role Objective: A key objective of this role is to lead the Optical Engineering team in IOL optical design, IOL power calculation and design-file documentation, ensuring technical accuracy, completeness and compliance with applicable ISO standards. The role is responsible for providing technical support to IOL Production, reviewing and approving power calculations and design files, overseeing IOL power calculation tools (web and mobile), maintaining audit-ready ISO compliance records, and supporting CAPA and root-cause investigations related to optical engineering. The position will serve as the primary technical liaison with cross-functional teams, international customers, external partners, clinicians and academic institutions, and will contribute to resource planning and development of the Optical Engineering team. Desired Candidate Profile: Education Minimum: B. E./B. Tech or M. Tech/M. S. in: Optics / Optical Engineering Physics Desirable: Prior exposure to ophthalmic devices, particularly Intraocular Lenses (IOLs). Experience Requirement Minimum:
Relevant experience in optical design / optical engineering. Desirable: Experience in IOL design, IOL power calculation or ophthalmic medical-device development. Experience in mentoring or supervising junior engineers and trainees. Exposure to working with cross-functional teams in a regulated medical-device environment. Role Requirements Working knowledge of ISO 13485, 21 CFR Part 820, ISO 11979 series and ISO 14971. Experience in design-file documentation, traceability and maintenance of audit-ready records under a Quality Management System. Exposure to CAPA, non-conformance and root-cause investigations. Solid technical documentation and report-writing skills. Role & Responsibilities: Lead and supervise the Optical Engineering team, comprising Optical Engineers and trainees, in IOL optical design, power calculation and design-file documentation activities, including work allocation and review of technical output f
📌 Optical Engineer (Gujarat)
🏢 Biotech Healthcare
📍 Gujarat