Wondfo USA

Systems Engineer:
1. Engage in hands-on fabrication and testing of sub-systems and devices
2. Manage resolution of systems engineering issues including architecture, hardware, and software design tradeoffs
3. Development, test, and integration of complex electrical components and subsystems (including PCBs, cables, system interconnect)
4. Engage in intra-company collaboration between electrical, firmware, mechanical, product, manufacturing, and operations
5. Work towards the development and maintenance of system product specifications, requirements documents, hazards analysis documents, usability and V&V documentation, and other technical documentation
6. Perform Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed
7. Ensure electrical design and documentation complies with medical safety standards

Quality Engineer:
1. Setup Quality control system at Wondfo USA for 5D project and future product development
2. Work with the R&D team to develop and maintain the SOPs and QC-related documents
3. Vendor qualification and engagement, define and establish the quality system and manufacturing capability
4. Work with the R&D team to Participate in root cause analysis initiatives to determine proper corrective and preventative action
5. Integrate the QC system into the product FDA for the regulation process
6. Hands-on design, execution, and analysis on microfluidic and subsystem integration for diagnostics applications 
7. Systematically design, execute, and document experiments to ensure product quality and reliability requirements are met
8. Collaborate cross-functionally with assay and analytical instrumentation development teams to conduct platform-level troubleshooting, analysis, and validation
9. Employ critical thinking and hands-on problem solving to resolve project challenges in a timely manner
10. Work hand-in-hand with Operations to facilitate smooth transition of product into manufacturing

Systems Engineer + Quality Engineer

University of Missouri-Columbia

Engineering Analysis of Bioprocesses (Fall 2018, 2019 & 2020)
Heat and Mass Transfer in Biological Systems (Spring 2019 & 2020)
Professional Development in Engineering (Spring 2020)

Graduate Teaching Assistant

- Design, and fabrication of 3D printed/ PDMS cartridges using oxygen plasma and photolithography for in-situ culture and measurement
- Design and run multiple experiments to Test various equipment for microbial detection

Graduate Research Assistant

Customer Service Attendant

ImpeDx Diagnostics

-Fabricated a medical device prototype to perform automated blood-culture readings to detect bacterial growth accounting for incipient infection in blood samples.
-Developed and execute test protocols, experiments, process characterization, and process validations on new and revised microfluidic cartridges.
-Validated the sensitivity of an economical electrical device (MOKU Lab) as an alternative to the expensive Impedance analyzer (Keysight-4294).
-Designed, assembled, and tested MICROFLUIDIC cassettes for in-situ culture(s) and measurement.

Product Development Intern

Amritsar College of Engg. & Tech, Amritsar

- Established liaison between industry and the Department of Mechanical Engineering to assist in the -recruitment of mechanical engineering undergraduates.
- Inviting, hosting, and managing the engineering career fair.
- Organizing and conducting industrial visits for mechanical engineering undergraduates to several process-based industries.

Training and Placement Coordinator 

Skybird Agro Industries - India

Title: Quality Supervisor (Oct 2014-Jul 2017)
Profile: Engaged in Design & manufacturing of molded products and assembled products.
Job Responsibilities:
1. Routine monitoring of Quality work-activities on the shop floor.
2. Conducting daily quality-meeting and analyzing daily in-house process rejections and taking necessary corrective-action and reporting the same to our customer.
3. Registering, Analyzing, and taking corrective action for all Customer complaints.
4. Monitoring the effectiveness of the countermeasures.
5. Preparing Inspection Services Activity Report (ISAR), Production Part Approval Process (PPAP) documents for the newly developed parts.
6. Preparing Automated Optical Inspection (AOI), Process flow chart, FMEA, Control plan and 4M change report for all the new development products, EO change, etc.
7. Preparing MSA, SPC, Product, and Process audit reports as per the plan.
8. Calibration Planning of Equipment & Gauges.
9. Validation of master samples as per the plan.
10. Conducting training for operators, PDI, and quality inspectors as per the schedule.

Title: Quality Engineer (Jul 2012 to Sep 2014)
Profile: Producing various types of agro-based sprayer parts like Cap, Clamp, Clip, Connector, Holder, Plug etc.
Job Responsibilities:
1. Carrying Out CAPA/Why-Why analysis/8D Report/SQCR, Layout Inspection, MSA, SPC, Control Plan, FMEA, Internal-External &Supplier Rejection Analysis, COPQ, etc..
2. Randomly Verifying Molded & Assembled Products dimensions, color, weight, texture, strength and fitment, incoming/Outgoing materials status.
3. Randomly monitoring product testing methods and inspecting products in order to make sure that they meet specified standards.
4. Carrying out Hygiene, Safety, 5S & Kaizen practice in All over the plant.

Training Attended:
a. ISO 14001 - 2015 Environmental Management System
b. Total Quality Management – Quality Systems, Statistical Process Control & FMEA
c. 5s Implementation

Quality Assurance Quality Control Engineer

Sai Institute of Engg. & Tech, Manawala

Lecturer

Godrej & Boyce Mfg. Co. Ltd.

- 6 months of training in the Quality/Production Planning and Control department.
- Completed a project on gaps in the implication of JIT by analyzing manufacturing operations.
- Completed a project on Supply chain management involving the optimization of inventory.

Engineering(QE) Co-op 

Northern Railways Mechanical Workshop

- Completed 6 weeks summer internship as a Quality analysis and control intern.

Summer Intern

Systems | Quality | Operations | Medical Devices

Highly skilled and results-driven Systems Engineer with expertise in medical device development, risk management, verification and validation, and technical support. Proven track record in leading cross-functional teams and delivering successful projects. Proficient in ISO standards, DFSS, and GD&T. Strong analytical and problem-solving abilities with a commitment to quality and compliance. Experienced in conducting experiments, data analysis, and documentation for regulatory purposes. Excellent communication and training skills to provide technical support to customers. 

-MS in Biological Engineering and Mechanical Engineering.
- Certification in FDA Regulatory pathway.
- Certification in Medical Device Quality Management Regulation (21 CFR 820, ISO 13485).
- Certification in Six-sigma Green Belt with knowledge of Lean manufacturing, 5S, and JIT.

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