Role Objective:

A key objective of this role is to lead the end-to-end R&D; strategy, technology roadmap and product-development execution for the Ophthalmic Instrumentation Division, covering diagnostic and treatment systems.

The role is responsible for providing technical and organizational leadership across optical/opto-mechanical design, electronics, embedded systems, firmware, software and systems integration; driving product development from concept through commercialization; ensuring design-control and regulatory compliance; and establishing a high-performing multidisciplinary instrumentation R&D; organization.

Desired Candidate Profile

Education

Minimum:

B.E./B.Tech, M.Tech, M.S. or Ph.D. in:

- Optics / Optical Engineering
- Biomedical Engineering
- Electronics

Desirable:

- Advanced technical qualification with specialization in optical systems, biomedical instrumentation, electronics or medical-device engineering.

Experience Requirement

Minimum:

- 10 years of progressive R&D; experience in medical-device instrumentation.
- Significant hands-on and leadership experience in ophthalmic diagnostic and/or treatment systems.
- Experience managing instrument development from concept through commercialization in a regulated environment.

Desirable:

- Experience with systems such as:
- Biometers
- Topographers
- Tonometers
- OCT
- Fundus / anterior-segment imaging systems
- Ophthalmic lasers
- Phacoemulsification systems
- Surgical consoles
- Experience leading multidisciplinary optics, electronics and embedded-software teams.

Role Requirements:

- Strong working knowledge of ISO 13485, 21 CFR Part 820, IEC 60601 series, IEC 62304, IEC 62366 and ISO 14971, with experience in design controls, verification and validation, and risk management for active/electromechanical devices.
- Proficiency in optical and opto-mechanical design tools (Zemax or equivalent).
- Experience in international regulatory submissions (CDSCO, CE/MDR and US FDA) for diagnostic or treatment-class medical devices.
- Proven track record in technology evaluation, build-versus-buy assessment, supplier/OEM partnerships, and licensing or technology-transfer negotiations for instrumentation products.

Role & Responsibilities

1. Own the end-to-end R&D; strategy and technology roadmap for the Instrumentation Division, covering ophthalmic diagnostic and treatment systems.
2. Lead,



build and mentor a multidisciplinary R&D; team spanning optical/opto-mechanical design, electronics and embedded systems, software/firmware and systems integration.
3. Direct opto-mechanical and electro-optical system design for recent diagnostic and treatment platforms using Zemax or equivalent optical-design tools, ensuring that performance, manufacturability and cost targets are achieved.
4. Oversee embedded hardware, firmware and application-software development and lifecycle management for connected diagnostic and treatment devices, ensuring compliance with IEC 62304 and applicable cybersecurity and data-integrity requirements, including validation, release control and user documentation/IFUs.
5. Own design control and regulatory compliance for instrumentation R&D; in accordance with ISO 13485, 21 CFR Part 820, IEC 60601-1 (electrical, mechanical and thermal safety), IEC 60601-1-2 (EMC), applicable laser-safety standards such as IEC 60825-1, and ISO 14971 risk management.
6. Drive product development from concept through prototyping, verification and validation (V&V;), design transfer and commercialization for diagnostic and treatment systems.
7. Act as the senior technical interface with cross-functional teams for domestic and international registrations (CDSCO, CE/MDR and US FDA, as applicable), audits, technical documentation and Design History Files.
8. Provide technical oversight to the manufacturing and service functions on instrumentation-related issues, field complaints, CAPA and root-cause investigations, driving continuous product and process improvement.
9. Direct clinical evaluation and usability-engineering activities in accordance with IEC 62366, incorporating surgeon and clinician feedback into design iterations.
10. Lead technology scouting, evaluation and business development for the instrumentation portfolio, including assessment of build-versus-buy options, licensing, OEM and technology-transfer opportunities,



and strategic partnerships with instrument and component suppliers.
11. Build and maintain relationships with ophthalmic surgeons, hospitals and research institutions to support clinical trials, product validation, and market and technology intelligence.
12. Represent R&D; – Instrumentation in leadership and cross-functional forums, providing technical inputs for business planning, budgeting, capital expenditure and new-product introduction (NPI) decisions.
13. Establish and track departmental KPIs, project timelines and quality/reliability metrics for the instrumentation portfolio, and report progress and risks to senior leadership.
14. Ensure a strong quality, safety and compliance culture within the Instrumentation R&D; function, consistent with a regulated medical-device manufacturing environment.

Functional Skills Required

- In-depth knowledge of opto-mechanical and electro-optical system design for ophthalmic diagnostic and treatment instruments.
- Expertise in embedded hardware, firmware and application-software development in line with IEC 62304.
- Ability to manage prototyping, verification and validation (V&V;) and design transfer for active/electromechanical devices.
- Experience in handling field complaints, CAPA and root-cause investigations for instrumentation products.

Behavioral Skills Required

- Strategic thinking with the ability to align the instrumentation roadmap with business goals.
- Strong leadership skills to build and mentor multidisciplinary engineering teams.
- Effective communication and stakeholder management with internal teams, suppliers, surgeons and institutions.
- Analytical problem-solving and sound decision-making under technical and commercial constraints.
- High ownership, accountability and a results-driven approach to timelines and KPIs.
- Commitment to quality, safety and compliance.

Team Size to be Handled:

- 3 direct reports at Senior 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 (Ophthalmic Instrumentation) (Ahmedabad)
🏢 Biotech Healthcare
📍 Ahmedabad