Benson Babu Email and Phone Number

• Assure products meet regulatory requirements for risk management and reliability, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.• Collaborate at a systems level with R&D, Clinical, Data Analysis, reliability, and other key functions to develop a quantitative approach to risk management.• Providing Risk Management expertise and guidance to Post Market Surveillance Team ensuring consistent and accurate application of all Risk Management standards to Sleep & Respiratory Care personnel.• Monitors the Policy for Establishing Safety Risk Acceptability for each product and ensure the policy remains accurate• Determining if a new or revised Risk Management File and Risk Management Matrix is required• Approving iterations to a product’s Risk Management Plan

- Development of the Design for Reliability framework & deployment as a part of PDLM.- Support Data analysis and statistical modelling into product safety risk management files and fulfil riskbenefit modelling requirements associated with health hazard evaluation and field action decision.- Developed Failure rate analysis for Philips connected care and specially on Therapeutic care products(Automated external Defibrillators and Advanced Life Support) devices.- Ensuring quality system is compliant to internal Philips Quality system requirements initiatives, as well asother applicable regulations and standards.- Lead the role as a Product Owner in a scrum environment for Corrective action and preventive action.- Carried out Life Data Analysis and reliability prediction using Statistical tools.- Provides leadership, training to other support staff through One day workshops and SharePoint.- Actively Contributed for “Must Wins Strategy” in ECR business for CAPA support.- Performed Design FMEAs on all new products & recommend design changes for product reliability.- Actively involved in fulfilling requests for Audits from different competent regulatory bodies as TGA,TUV, FDA etc- Rated Excelling in 2021, Outstanding in 2020 and Exceeds expectations in 2019 for Philips Annual Performance reviews- Won the Local finals for the Philips Excellence Competition in 2020 and 2021.

Statistical Modelling of Post Market and Manufacturing data to identify potential improvements in device.Promote Quality culture and compliance to all regulatory requirements of a Class 3, pre-market approval device.Support Data analysis into product safety risk management files and fulfil risk benefit modelling requirements associated with health hazard evaluation and field action decision.Ensuring quality system is compliant to internal Philips Quality system requirements initiatives, as well as other applicable regulations and standards.Development of data trending from all QMS Sources.Deployment of the Design for Reliability framework as a part of the Philips product realization process and ensuring design for reliability activities implemented across each phases of project milestones.Carried out Life Data Analysis and reliability prediction by using Military and Naval Standards to ensure predictable design.

Reliability planning for new product development – Mobile, fixed and ceiling based diagnostic x-ray machines.Worked with key suppliers to insure reliability requirements are met.Defining classes of failures for clear definition for pass/fail criteria when conducting reliability test.Proposed changes in design or formulation to improve system and/or process reliability.Carried out Life Data Analysis and reliability prediction using reliasoft tools.Ensured that corrective measures meet acceptable reliability standards.Plan, Map and track the Design for Reliability activities with project time lines.Provides leadership, training to other support staff through One day sessions and SharePoint creation.Developed a predictable reliability modeling by defining a new metric “system availability” at the concept phase of the project and monitoring the same across each phases of the project milestone.AchievementsStar performer ”2015” & “2016” for developing system reliability scorecard and supplier reliability framework.Executed Design for reliability framework in three NPI’s and two subsystem projects within a span of 3 years.Rated “Outstanding” and “exceeds expectations” in the performance evaluation for year 2015 and 2016.Rated the best organization across Philips (scored 3.95 out of 5) practicing “Design for reliability” based on the Reliability maturity assessment conducted as part of I2M deployment conducted by Philips innovation services.

- Ensured that corrective measures meet acceptable reliability standards.- Plan, Map and track the Design for Reliability activities with project time lines.- Provides leadership, training to other support staff through One day sessions and SharePoint creation.- Developed a predictable reliability modeling by defining a new metric “system availability” at the concept phase of the project and monitoring the same across each phases of the project milestone.

- Leading the initiatives for warranty data analysis & inherent reliability for different product lines such as Tractors, Sprayers & C&F units.- Coordinates all product changes that are introduced to the factory from engineering - both running changes as well as changes made due to enterprise product delivery programs (EPDP). - Analyzing historical warranty data for benchmark products & predicting reliability for new releases.- Assists in developing reliability verification plans to help ensure engineering changes that are implemented into production have demonstrated adequate reliability growth and are introduced with minimal risk. - Led the efforts for initiation for new activities for targeting issues for low hour warranty failures during the visit to John Deere Netherlands factory and Des Moines factory, US.- Coordinated with different department to carry out the reliability activities as per project time lines.-Using tools such as Weibull ++, Blocksim and Lambda predict for Analyzing field Data.

Handling the reliability and quality projects for new vehicle launch by involvement in pre-series and pre-launch activitiesCarrying out process Audits for pre-launch vehicles so that process qualification is achieved for finalproduction and also carrying out regular Process Audits for already launched Vehicles so that all theprocesses are as per Standards of FIAT and for continuous improvements. Conformity of the product to the expectations of the customer by maintaining of internal indicators Carrying out backtracking on PDI, product Quality issues and coordinating with otherdepartments in solving the issues

- Implementing corrective and preventive action for quality control at shop floor- Achieve zero de-effects on shop floor by conducting process and product audits- To do root cause analysis, reduce rework at shop floor by 5S activities- Inspection of product under development- Investigation and solving of quality problems on assembly line, which related to fitment and function parameters as per customer specification.