Nirmalya Sengupta

Background

About Nirmalya Sengupta

Handledthe Global Hardware Engineering Managerrole for their DCAR business. This is the business that deals with ECG machines both resting and stress. My responsibilities were to ensure that all product development and Life cycle Management of existing and Legacy products. Part of my responsibilities were also to strategise on future product lines and portfolio. • • Had the responsibilities of ensuring Service support for the complete product range and that was inclusive of all Technical Product Documentation.Globally responsible Functional leadership responsibilities for all Hardware engineering Program portfolio Responsible for readiness for migration from MDD to MDR Regulations for current product range including OEM Products Range for DCARaccross Global Sites. • Led the team to file for 510K Certification of the CASE product Upgrade for the Stress ECG Product and ensured continuation of existing 510k Certification with Letter to File approachDue to no change in Intended nature of Use. • Responsible for ensuring Service preparedness for Product changes and Enhancements due to LCM Activities and normal Obsolescence and Vitality Activities.(Ensuring continuity of Production despite EndOfLife of Components and Modules along with Migration due to technology Changes/Upgradation. Responsible for Strategy Definition for Platform Definition and Design approach Within DCAR. Was the Single Point of Contact for Technical inputs and Support for Multiple MDSAP Audits Strong product development and project management professional with 22 years of experience in Lighting Solutions & Consumer Electronics organizations across worldwide development sites of Philips viz. Singapore, Belgium, Bangalore and Kolkata E2E Product development and successful commercialization of products in global markets for B2B and B2C ODM, JDM Management with partners like Fideltronik, Jabil. Vendor development for enriching the local eco system Extensive work experience in Consumer Electronics and Lighting Controls product development with strong PRP knowledge, tracking on budget, on time and on quality deliveries of projects with effective planning and stake holder management Good insight to the product regulatory requirements with hands on experience in handling multiple process and product certification audits with internal and external certifying bodies. Led cross functional, multi-site teams at various levels directly over 8 years with strong emphasis on people development