02 Oct
|
Biotech Healthcare
|
India
02 Oct
Biotech Healthcare
India
Job Description
Role Objective:
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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.
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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.
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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.
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Desired Candidate Profile:
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Education
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Minimum:
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B.E./B.Tech or M.Tech/M.S. in:
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- Optics / Optical Engineering
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- Physics
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Desirable:
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- Prior exposure to ophthalmic devices,
particularly Intraocular Lenses (IOLs).
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Experience Requirement
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Minimum:
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- Relevant experience in optical design / optical engineering.
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Desirable:
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- Experience in IOL design, IOL power calculation or ophthalmic medical-device development.
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- Experience in mentoring or supervising junior engineers and trainees.
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- Exposure to working with cross-functional teams in a regulated medical-device environment.
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Role Requirements
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- Working knowledge of ISO 13485, 21 CFR Part 820, ISO 11979 series and ISO 14971.
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- Experience in design-file documentation, traceability and maintenance of audit-ready records under a Quality Management System.
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- Exposure to CAPA, non-conformance and root-cause investigations.
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- Solid technical documentation and report-writing skills.
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Role & Responsibilities:
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- Lead and supervise the Optical Engineering team, c
📌 Optical Engineer (India)
🏢 Biotech Healthcare
📍 India