02 Oct
|
Biotech Healthcare
|
Ahmedabad
02 Oct
Biotech Healthcare
Ahmedabad
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:
• Solid 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-c
📌 General Manager – R&D (Ahmedabad)
🏢 Biotech Healthcare
📍 Ahmedabad