* 14+ years of progressive experience in New Product Design & Development, which includes medical devices, consumer, commercial, FMCG and Industrial products; jig & fixtures.* Experience in developing and executing project plan. Ensuring projects are delivered to the highest quality, within budget by efficiently organizing, managing and utilizing all resources.* Leadership and technical experience in developing Disposable, Reusable and Absorbable medical devices from inception to completion, i.e., from gathering & analyzing Voice of customer (VOC) and defining user requirements to Design Characterization and Design Transfer.* Expert in Plastic, Sheet metal, Machined parts, Elastomeric parts & Vacuum formed packaging.* Hands on experience in designing Rugged & IP-67 products per IEC standard 60529.* Knowledge of the DFM, DFA and design detailing in software like SolidWorks, ProE & Auto CAD.* Considerable knowledge in Anthropometric standards, Ergonomics & Usability factors.* Proficient in detail drawing, applying GD&T and Tolerance stack-up analysis.* Experience in Quality Management & Risk Management, QFD and FMEA (aFMEA, dFMEA, pFMEA) as per ISO 14971.* Experience in developing and executing Design Verification Plan and developing Test Methods.* Initiate, conduct & evaluate design Verification & Validation activities and Design Change Control.* Knowledge of FDA Regulatory compliance 510(k), ISO 13485:2003 and CFR 21 820 (QSR).