Vikash Bhatta Email & Phone Number

Baltimore, Md, Us

Madison, Wisconsin, Us

We are developing a multi-analyte blood-based diagnostic test that is designed for the detection of multiple types of cancer at earlier stages and be utilized as part of routine medical care. We are developing assays to measure levels of circulating proteins and identify somatic alterations in cell-free circulating tumor DNA to detect cancer in asymptomatic individuals.

Minneapolis, Mn, Us

I provided design assurance/reliability engineering support on new product development teams for R&D in Cardiac and Vascular Group (CVG). As part of R&D project teams, I helped define, contribute, and execute the overall reliability related programs in collaboration with cross-functional teams and provide leadership for Design for Reliability (DfR), guidance to technical issues, engagement in design and risk reviews, and contribute to development activities.Responsibilities included:• Develop, coordinate and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.• Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.• Plan, lead, execute, and integrate Risk Management activities, to demonstrate product safety.• Ensure corrective measures meet acceptable reliability standards.• Analyze preliminary plans and develop reliability engineering programs to achieve company, customer and governmental agency reliability objectives.• Develop mathematical models to identify units, batches or processes posing excessive failure risks.• As necessary, propose changes in design or formulation to improve system and/or process reliability.• Determine units and/or batches requiring environmental testing and specify minimum number of samples to obtain statistically valid data.• Plan, lead, execute, and integrate Design for Reliability (DfR), to quantify product reliability.• Plan, lead, execute, and integrate test and assessment activities, to demonstrate product performance and compliance.• Perform engineering reviews of quality records for compliance with stated requirements and impact on safety and reliability.• Apply knowledge in applicable standards, requirements, specifications, and required quality and reliability practices in assigned area.

I supported new product development in Cardio & Vascular group of Integer for the development of diagnostic and interventional cardiac and endovascular devices by ensuring that the desired design performance is achieved meeting applicable medical device FDA/European regulatory requirements and company’s policies and procedures. Responsibilities Included:- Lead Design Verification/Validation and Risk Management related activities for the the development of a novel EP mapping catheter - Lead Design Verification/Validation and Risk Management related activities to support the previously released guidewire product families- Lead/Participate in qualification activities related to changes in production or vendor-related processes- Participate in development teams to perform quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled- Lead Risk Management (ISO 14971) activities as related to new product development and previously released products- Work with NPD group in the development of test fixtures and production acceptance criteria and test methodology- Coordinate sourced item qualification activities and support supplier risk management initiatives- Conduct review of DHF and Technical Files- Provide support in conducting root cause analysis

As a Quality Engineer, I supported the Sensing and Control group at Entegris for Pressure Transducers, Proportional Control Valves, Flow Meters, Flow Controllers and Concentration Analyzer product categories that are used extensively by our customers in Semiconductor and Life Sciences industry. Responsibilities Included: - Developed, implemented and maintained technical quality assurance and control systems - Led 8D Problem Solving Teams in failure analysis, root-cause identification and corrective andpreventative action for manufacturing defect resolution - Participated on New Product Development Teams - Authored and analyzed results of validation and qualification protocols for products, processes andequipment - Used lean sigma tools such as- DMAIC, 5-Whys, Pareto diagram, SPC, Gage R&R, CapabilityAnalysis, ANOVA and DOE, among others, to analyze and improve quality levels - Ensured feedback, corrective action communication and implementation were consistent withinternal and external customer expectations - Drove continuous improvement projects - Participated in and reviewed timely implementation of material disposition decisions for blockedstock - Provided training and leadership to the quality and manufacturing divisions - Developed and maintained audit functions - Ensured quality engineering systems and products were consistent with internal documentation,standards and customer requirements

As a Quality Engineer, I supported the Sensing and Control group at Entegris for Pressure Transducers, Proportional Control Valves, Flow Meters, Flow Controllers and Concentration Analyzer product categories that are used extensively by our customers in Semiconductor and Life Sciences industry. Responsibilities included:- Led over 250 8D Problem Solving Teams in failure analysis, root-cause identification and corrective and preventative action for manufacturing defect resolution- Participated on New Product Development Teams- Authored and analyzed results of validation and qualification protocols for products, processes and equipment- Used lean sigma tools such as- DMAIC, 5-Whys, Pareto diagram, SPC, Gage R&R, Capability Analysis, ANOVA and DOE, among others, to analyze and improve quality levels- Represented Quality department in daily MRB meetings- Ensured quality engineering systems and products were consistent with internal documentation, standards and customer requirements

Minnetonka, Mn, Us

I worked in the New Product Development group of Vishay that catered to most of the leading medical devices companies in the development of inductor-coils, transformers, antenna coils and other critical electrical components. Following are the highlights of my tenure at Vishay:- Led three new product developments from prototype to production stages using the design-for-manufacturing principles - Utilized Lean/Six-Sigma principles to set up prototype/production lines that were capable of producing parts that met the stringent 1.33 PPK customer requirement- Prepared FMEA on multiple projects to help systematize failure analysis- Prepared a Control Plan document for an antenna coil manufacturing project to assure that all the process outputs were stable.- Performed a detailed characterization experiment to optimize the winding process of an antenna coil using factorial DOE and Response Surface Methods (RSM)- Performed a Taguchi DOE to optimize the coil-to-case adhesion for a flyback transformer produced at the plant- Developed and performed IQ/OQ/PQ on various manufacturing equipment and processes in use at the plant - Performed CAPA analysis on various projects to help with the root cause investigation based on the customer complaints- Provided design input to assist with the manufacturing tooling/fixture design and fabrication- Created daily and weekly 5S- Audit checklist for the workstations - Designed and fabricated a micro-controller based temperature control system for use with coil-winding machines that require hot-air bonding

Minnetonka, Mn, Us

- Performed failure modes and effects analysis (FMEA)- Prepared installation qualification (IQ) and operational qualification (OQ) reports- Planned and performed measurement System Analysis (Gauge R and R)- Planned, performed and analyzed Taguchi DOE and Factorial DOE

- Designed a new floor layout and material handling plan- Prepared manufacturing operations work-packages for a production line that made parka jackets- Performed time-studies and line balancing analysis using Minitab and WinQSB tools

Dhulikhel, Bagmati, Np

- Taught various engineering courses to undergraduate students- Devised and supervised laboratory experiments and engineering projects

Master, Engineering Management

Bachelor Of Engineering, Electrical And Electronics Engineering