Risk Management activities for Infusion System including Infusion pumps and Infusion Pump Docking & Connectivity Station(s) in compliance with international Standards IEC/ISO 14971:2019, IEC/ISO 60601-1.Prepare Risk Management Plan and establish risk acceptance criteria.Perform System/Functional FMEA by analyzing System Architecture in the early phase of development to identify & mitigate potential undesired states/End Effects leading to System Hazard(s).Work with Subsystem Lead(s) to flow-down System level failures to Subsystem FMEAs and vice-versa to make sure that the complete chain of lower level causes leading to undesired System End Effects is identified and mitigated.Identify foreseeable sequence of events that can lead to hazardous situation(s) and estimate risk(s) associated with each event.Devise and document mitigation strategies/risk controls to eliminate/reduce these risk(s).Collaborate with Cyber security lead to analyze the potential patient safety risk(s) arising from existing vulnerabilities in the system and support decision making in mitigating these risk(s). Collaborate with Human Factors lead to analyze use related risk(s) and identify risk mitigations in the form of Device Instructions for Use (IFU) including warnings and cautions as applicable.Collaborate with System lead to derive safety requirements including labelling from the Risk Controls and establish traceability with Design Inputs for demonstrating effectiveness of these controls in Design outputs during Verification.Evaluate residual risk & collaborate with clinical team in preparing Clinical Risk Benefit Analysis based upon the residual risk. Support preparation of Safety Assurance Case (SAC) as required by the applicable regulatory agencies to demonstrate the safety of product using per the framework laid out in AAMI TIR38. Participate in FDA 510(k) Submission activities and continuous engagement with FDA for the Additional Information (AI) requests after the submission.

Headed Lithium Battery Project as Functional Lead and managed the complete project administration including finalizing requirements with customers, defining product specifications and coordinating with cross-functional departments for executionDelivered Lithium-Ion Battery Packs with 18650/21700 cylindrical & prismatic cells for electric vehicles & stationary applications having desired IP ratingsImplemented thermal management in Lithium Battery Packs using various strategies such as PCM & Cooling platesDeveloped swapping & charging stations for batteries of three wheelers to eliminate the charging time & increase vehicle rangeDeveloped architecture for new systems & researched new technologies through existing/potential vendors aimed at meeting customers’ requirementsIdentified resource needs and participated in recruiting efforts to expand the team to achieve organizational objectivesLed and mentored a team of engineers to maximize their contributions. Set clear roles & responsibilities to enable the implementation of business strategies

Collaborated with cross functional teams like Sales & Marketing, Technical Support, Procurement, Operations and Quality to determine product requirements\specifications for new product development initiatives and also for making required modifications in the existing products Undertook ownership of sub-systems of next generation intra-oral medical device and drove their design to completion per functional requirements specifications(FRS) adhering to the accelerated product development process defined by the company and following the applicable design controls – FDA 21 CFR 820 & IEC 60601-1 Interfaced with manufacturing during design transfer & resolved issues related to manufacturability, quality & cost Participated in FMEA & risk analysis activities to identify, evaluate & mitigate the potential failures & risks associated in use and foreseeable misuse situations.Performed tolerance stack-ups on designs for worst & statistical case scenarios based upon Critical-to-Quality(CTQ) dimensions Initiated Value Engineering activities for cost reduction, quality & reliability improvement in the existing line of products Travelled to support on-site design activities in USA & China as required to ensure completion of projects within the committed time frame and to participate in required trainings to learn new technologies/processes aligned with business goals Participated in recruitment process to expand team in India after discussing the strategic business requirements with Global Teams in USA & Europe & mentored new team members on new product development/sustaining procedures as required to achieve business targets Assisted global team in carrying out the annual performance reviews by providing accurate information on individual staff member’s performance in India Evaluated training needs and scheduled development programs for junior staff members as per the feedback in performance reviews and future business requirements

Supported new product development initiatives with key focus on quality, cost & timely deliveryDeveloped a new By-Pass valve for existing cartridge for residential applications closely working with team in Brookfield, USACoordinated with FEA team to provide inputs & boundary conditions to be used for simulations on the purposed design concepts to visualize the performance against the set parameters and verify the results with physical testingProvided solutions to existing problems in filtration components for ease in manufacturing & assemblyHandled Value Engineering projects for cost reduction, design optimization and quality improvementsProvided sustaining engineering support on site at Brookfield, USA for 3 monthsExecuted ECNs to reduce product costs, improve Manufacturability, Quality and for Material and/or Supplier Change