Lead R&D, Manufacturing, Quality, Regulatory, Services Delivery, Business Development, Collaborations and Partnerships for IZiel Healthcare

Lead R&D, Production, Purchasing, Quality and Regulatory functions for IntegriMedical.

Responsible for managing product design and development for two products going through remediation. Leading two teams through product remediation to establish Product & Design requirements through VOC, Systems Engineering, Transfer Function Development using finite element analysis and simulation with Design for Six Sigma. In addition lead complete process validation activities that includes test method validations, process characterization and operational and process qualification activities for creating a complete DHF. Effectively managing a team with onshore / offshore model (ratio 1:4) located in Minneapolis, USA and Chennai, India. Develop schedules and track real-time project progress through a combination of classical critical chain management and scrum methodologies.

See Boston Scientific position above. Company was acquired by Boston Scientific Corporation in August 2015.

Program Manager and Master Black Belt for Design for Six Sigma (DFSS) Implementation in CRDM division of Medtronic. One of the first Black Belts to be certified through the Medtronic DRM - DFSS program and selected for the Master Black Belt program. Area of focus is Voice of the Customer and Robust Design. Trained, coached and mentored hundreds of candidates through the Green Belt certification program. Coached and mentored projects in the business function in the area of Market Development, Upstream Marketing, Voice of the Customer, Unmet Needs collection and prioritization and Portfolio decision making. Coached and mentored projects in the R&D function in the areas of Requirements Management, Predictive Engineering, Transfer function generation, Robust Design, Design of Experiments, Capability and Control.

Design and manufacture Class III medical devices such as Cardiac Implantable Pacemakers (IPG) and Defibrillators (ICD). I have worked on the following aspects of Product Design:- Requirements management for mechanical platforms of ICD and IPG. Coached systems engineers and product development sub-teams on doing requirements management using Cognition Cockpit. - Concept Engineering: Formally trained in TRIZ (Theory of Inventive Problem Solving), involved in several product concept generation and selection activities.- Robust Design and Predictive Engineering: Defining the mechanical configuration of IPG’s and ICD’s in terms of defining the overall shape and size of devices using ergonomic considerations. My responsibilities included designing the overall device package along with interconnects and mechanical features and elements like patient alert, flexible circuits, insulators, component fixation and injection molded polymer connector modules. Requirements Management and Transfer Function development using modeling and testing with tools such as Finite Element Analysis, Monte Carlo Simulations etc. and virtual and practical Design of Experiments. - Verification and Validation Testing: I have performed verification of requirements and validation testing for Consulta / Secura ICD platforms. I have developed next generation testing methodology to predict reliability using accelerated life testing and time temperature superposition to predict long term aging and performance. - Cross Functional Team Collaboration: I have worked with cross functional teams from Switzerland and Puerto Rico to incorporate design for manufacturability and high process capability into designs. I have worked with cross functional teams to conduct Fault Tree Analysis, Design and Process FMEAs to identify key failure modes and create appropriate action plans to address them.

Graduate Teaching Assistant for a Capstone Design Class. Taught Mechanical Engineering Design and Problem Solving using TRIZ to graduating Mechanical Engineering Students. Assisted Dr Eugene (Evgeny) Rivin - A TRIZ Master, in coaching and mentoring students and guiding them through their Design Projects from concept generation to final performance validation. Coached and mentored around 75 students and 20 projects some of which led to patentable design solutions.

Role and Job Description: Design of Heavy Commercial VehiclesDesign: Design of Chassis, Brakes, Suspension, Steering, Exhaust, Controls, Fuel, and Hydraulic systems through concurrent engineering practices using Computer Aided Design and Finite Element Analysis platforms such as Pro-Engineer, Pro-Intralink and Pro-Mechanica.Project Management: Lead and manage vehicle design activity by coordinating the efforts of various design cross – functional teams such as Vehicle Engineering, Engines, Power Train, Cab & Auto Electrical, and Vehicle Testing as well as suppliers both international and local. Role specifically included coordinating vehicle design integration by schedule and cost management as well as resolving design conflicts between various design groups to ensure smooth and timely execution of the project based upon project timing requirements.