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, new-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

- Solid 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

1. Own the end-to-end R&D; strategy and roadmap for the organization’s IOL portfolio, ophthalmic implantable devices and ophthalmic surgical items, in alignment with business and regulatory objectives.
2. Lead, mentor and build the Optical Engineering R&D; team, including allocation of resources, setting of objectives and review of technical output across all active projects.
3.



Provide overall technical direction for the optical design of new and existing IOL models using Zemax or equivalent software, including power calculation methodology and design-file documentation.
4. Drive the design and development of new ophthalmic implantable devices and surgical items from concept through design verification and validation, design transfer and commercialization.
5. Own the regulatory strategy and compliance of R&D; deliverables in accordance with ISO 13485, 21 CFR Part 820, ISO 11979 series and ISO 14971, including risk management files, Design History Files and technical documentation.
6. Act as the senior R&D; interface with cross-functional teams for domestic and international product registrations, submissions and audits.
7. Oversee R&D; protocol development, execution and reporting for international customers under the applicable Quality Agreements.
8. Provide senior technical oversight to the manufacturing function on product-related issues, root-cause investigations, CAPA and continuous improvement for IOLs, implantable devices and surgical items.
9. Direct clinical-affairs activities relevant to R&D;, including PMCF and clinical-study design inputs, outcome and rejection-trend analysis, and competitor and technology benchmarking, to guide product-development priorities.
10. Lead strategic technology evaluation and business-development activities, including assessment of new technologies, evaluation of technology-transfer and licensing opportunities, and negotiation and management of collaboration and IP agreements with external inventors, doctors and institutions.
11. Own and govern the development, verification and lifecycle management of IOL power calculation tools (web and mobile platforms), including functional requirements, validation and user documentation.
12. Build and sustain strategic relationships with doctors, hospitals,



universities, optical engineers and advisory boards, including conducting advisory-board and physician meetings across relevant platforms, to support innovation pipelines, clinical collaboration and market insight.
13. Represent R&D; in cross-functional and leadership forums, providing technical inputs for business planning, budgeting, capital expenditure and current-product introduction decisions.
14. Establish and monitor departmental KPIs, project timelines and quality metrics, and report R&D; performance and risks to senior leadership.
15. Ensure a strong quality and compliance culture within R&D;, with personal and team conduct maintained at high professional standards appropriate to a regulated medical-device manufacturing environment.

Functional Skills Required

- Ability to manage product development through design verification and validation, design transfer and commercialization.
- Experience in root-cause investigations, CAPA and continuous improvement for manufactured products.
- Capability in technology evaluation, technology transfer, licensing and IP agreement management.
- Knowledge of lifecycle management of software applications, such as IOL power calculation tools (web and mobile).

Behavioral Skills Required

- Strategic thinking with the ability to align R&D; priorities to business goals.
- Robust leadership and people-development skills to build and mentor high-performing teams.
- Effective communication and stakeholder management with internal teams, international customers, doctors and institutions.
- Negotiation and relationship-building skills.
- High ownership, accountability and a results-driven approach to timelines and KPIs.
- Commitment to quality, compliance and high professional standards.

Team Size to be Handled:

- 5 direct reports at Manager and Assistant Manager level.

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.

📌 General Manager – R&D (IOL & Ophthalmic Implants) (Ahmedabad)
🏢 Biotech Healthcare
📍 Ahmedabad