Deepak Bharambe

• Lead the medical diagnostics (IVD) development projects to deliver the product portfolio and roadmap in alignment with business strategy, balancing the scope, quality, time and budget. • Project initiation, project planning, stakeholder management, project reporting, budget ,resource management. • Project reviews, Design Reviews, enable project escalations/decisions as per the needs with relevant stakeholders. • International product registrations collaboration, deficiency letter remediations.

• Project planning, scheduling for customer request for standard product platform and customized injector pens (combination products), interface with key account managers, engineering, and relevant departments. • Cross functional team building and daily basis collaboration, cross site interactions with stakeholders, Suppliers • Design verification, Design transfer ( ISO 11608). • DHF Documentation ISO 13485, ISO 14971 (CE/FDA)

• Planning, co-ordination and testing of drug delivery devices with respect to pen standards of ISO 11608, dose delivery, drop test .Procedures as per ISO 13485 and risk management as per ISO 14971. • Cross functional interaction with stakeholders , suppliers for prototypes, various departments. • Design and development of hand-held, self-administered insulin Drug delivery platform-systems for diabetes. • Risk management focused on usability/human factors, safety and regulatory aspects.

• Lead Product Lifecycle activities engaging stakeholders across different functions like quality, sourcing, production and regulatory affairs teams with respect to medical device Quality management systems. • Change control board , executing and implementing engineering changes , using QMS ISO 13485 . • Risk management file maintenance for platform and family products as per ISO 14971. • Application of DFSS, Lean methodologies, Green belt certified from GE.