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.
- Strong technical documentation and report-writing skills.

Role & Responsibilities:

1. 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 for accuracy and completeness.
2. Provide theoretical and technical support to cross-functional teams, including IOL Production, for the resolution of product- and process-related issues,



and escalate unresolved technical matters with recommended corrective actions.
3. Identify and interpret applicable ISO standards (ISO 11979 series, ISO 13485 and ISO 14971), and ensure that the team’s design and documentation practices remain aligned with current requirements.
4. Review and approve IOL power calculations prepared for cross-functional teams, ensuring accuracy and adherence to agreed turnaround times for customer-facing requests.
5. Review and approve design-file documentation for IOL models prior to submission, ensuring traceability and completeness in line with the Quality Management System, and oversee the filing of ISO compliance records so that documentation remains audit-ready at all times.
6. Act as the primary technical liaison with cross-functional teams, coordinating technical inputs for regulatory submissions and project-related decisions.
7. Manage the development and execution of R&D; protocols for international customers, including protocol review, data interpretation and technical reporting.
8. Guide and review the design of new IOL models using Zemax or equivalent optical-design software, mentor engineers on optical-design methodology, and validate design outputs.
9. Direct the development and enhancement of IOL power calculation tools across web and mobile platforms, in coordination with software/IT teams, including definition of functional and validation requirements.
10. Establish and oversee a schedule for regular verification of the IOL power calculation tools, ensuring that verification records are maintained and discrepancies are investigated and resolved.
11. Ensure timely preparation and updating of user manuals and documentation for the IOL power calculation tools, for both customers and internal stakeholders.
12. Coordinate technical support for optical instruments, including troubleshooting, calibration oversight and liaison with instrument vendors.
13.



Serve as a key point of contact between the organization and external industries/partners for technical support and technical service matters.
14. Build and maintain professional relationships with doctors, universities and optical engineers to support clinical collaboration, technology evaluation and business development.
15. Support technology transfer and IP/collaboration agreements (e.g. with external inventors and clinical collaborators) from a technical due-diligence perspective.
16. Contribute to CAPA, non-conformance and root-cause investigations related to IOL design and optical engineering, and track corrective and preventive actions through to closure.
17. Support resource planning, training plans and performance inputs for the Optical Engineering team.
18. Maintain high standards of professional conduct and hygiene within the team, in keeping with the requirements of a medical-device manufacturing setting.

Functional Skills Required

- In-depth knowledge of IOL optical design and IOL power calculation methodology.
- Proficiency in Zemax or equivalent optical-design software.
- Knowledge of verification and lifecycle management of IOL power calculation tools (web and mobile).
- Technical support, troubleshooting and calibration coordination for optical instruments.

Behavioral Skills Required

- Supervision, coaching and mentoring of junior engineers and trainees.
- Strong analytical thinking and attention to detail.
- Clear written and verbal communication with internal and international stakeholders.
- Cross-functional coordination and relationship-building skills.
- High ownership and accountability for accuracy and turnaround times.
- Commitment to quality, compliance and high professional standards.

Team Size to be Handled:

- Optical Engineers and trainees within the Optical Engineering team.

Important Links: Website: https://biotechhealthcare.com/

LinkedIn: https://www.linkedin.com/company/biotechhealthcare/

Instagram: Biotech Vision Care

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

📌 Optical Engineer – IOL Design (Ahmedabad)
🏢 Biotech Healthcare
📍 Ahmedabad