Work Experience

Manufacturing Engineering

Abbott Laboratories ........................................................................................................................................................................ Dec, 2021 - Present

Division:- Structural Heart

• Lead New Product Integration (NPI) projects for 148 models across 19 products of Structural Heart division in compliance with EU-MDR Regulations to ensure seamless transition of new products into existing manufacturing systems to support EU market on and from Windchill PLM to Company’s Enterprise Resource Planning software (SAP) and SAP to Manufacturing Execution System (MES) where applicable.

• Manage NPI projects by developing and maintaining project plans, tracking progress, and reporting on key milestones and deliverables. Coordinate with stakeholders to align objectives, manage risks, and ensure project timelines are met.

• Collaborate with cross-functional teams to define project scope, timelines, and deliverables for the new product integration process. Develop detailed project plans and identify resource requirements.

• Develop and optimize manufacturing processes and procedures for the new product, considering factors such as equipment selection, assembly methods, material handling, and quality control. Conduct time and motion studies to identify bottlenecks and streamline operations.

• Plan and execute the transition from small-scale production to full-scale manufacturing. Determine production capacities, assess resource requirements, and coordinate with production teams to ensure smooth ramp-up and efficient utilization of resources.

• Develop and maintain detailed manufacturing documentation, including work instructions, and standard operating procedures (SOPs). Ensure that manufacturing processes are properly documented to ensure consistency and compliance.

• Work closely with cross-functional teams, such as design engineers, supply chain specialists, quality control personnel, and production operators, to ensure effective communication and collaboration throughout the NPI process. Coordinate efforts and resolve any issues or challenges that arise during integration.

• Ensure that manufacturing processes and documentation comply with relevant industry standards, regulations, and quality management systems, such as FDA regulations, ISO standards, and Good Manufacturing Practices (GMP).

• Author manufacturing test method validations to perform process validation activities and peer review cross functional teams’ (R&D, Development Quality, Packaging, Labeling Team, Technical Publications, Product Stewardship, and many more) test methods.

• Oversee development builds associated with the project using special work requests from multiple product design teams.

• Perform gap analysis of existing product documentation and processes and lead the engineering change management process on Windchill PLM to bring the systems up to current Quality Management System standards, Environmental Management Systems (EMS), and other regulatory requirements.

• Assess and edit inspection and test method validation documents to bring them up to current ISO:13485 standards and author technical justifications.

• Review/Author Engineering Change Orders involving test methods validations, qualification protocols and reports, master material lists, manufacturing procedures, scaled design development plans, design verification reports and other technical documentation.

• Improve manufacturing and inspection procedures by performing documentation checks, implementing good documentation, and manufacturing practices, nonconformance investigation and root cause analysis.

• Provide technical mentorship to Engineers, Operators, and train shop floor personnel to perform custom product builds for testing purposes.

• Coordinate with cross functional teams (R&D, Development Quality, Quality Engineering, Regulatory affairs) to qualify class III devices and accessories to ISO:13485, EU-MDR, FDA and other regions’ medical device requirements.

• Coordinate with Supply Chain team and perform production planning of developmental builds using SAP and assess general safety and performance requirements checks of State-of-the-Art class III medical devices (heart implants) per the U.S. Food and Drug Administration (FDA) and European Union Medical Device Regulations.

• Respond to technical questions posed by regulatory Notified Bodies such as BSI (British Standard Institution) related to Class Ill medical devices and corresponding accessories.

Mechanical Engineering

Arizona State University ............................................................................................................................................................ Jun, 2021 - Dec, 2021

• Designed Rotatable Covered Cavity (RoCC) kilns products on Solidworks to the requirements set forward by the engineering design team and develop new test protocols and draft reports based on test findings. Created technical design documents based on research of RoCC kilns.

• Collaborated with cross-functional teams, including design engineers, industrial designers, and product managers, to conceptualize and develop new products. Contributed to the design process, providing mechanical engineering expertise to ensure product feasibility, functionality, and manufacturability.

• Utilized computer-aided design (CAD) software to create detailed 3D models and technical drawings of product components and assemblies. Worked closely with prototype development teams to produce physical prototypes for testing and validation.

• Performed engineering analysis and simulation using tools such as finite element analysis (FEA) and computational fluid dynamics (CFD) to evaluate product performance, structural integrity, and thermal characteristics. Optimized designs based on analysis results.

• Collaborated with manufacturing engineers to ensure designs are optimized for efficient and cost-effective production. Considered manufacturing processes, material selection, assembly methods, and design for assembly (DFA) principles to enhance manufacturability.

• Developed and executed test plans to validate product performance and reliability. Conducted various tests, including mechanical and functional tests, stress testing, and durability testing, to ensure product compliance with specifications and industry standards.

• Identified potential risks and failure modes during the product development process. Performed risk assessments, implement design mitigations, and ensure compliance with applicable safety regulations and standards.

• Worked closely with cross-functional teams, including electrical engineers, software engineers, and manufacturing specialists, to ensure effective communication and collaboration throughout the NPD process. Coordinated efforts and aligned objectives to meet project milestones and deliverables.

• Prepared technical documentation, including design specifications, engineering drawings, bills of materials (BOMs), and assembly instructions. Maintained accurate records and documentation of design iterations, design changes, and design history.

• Managed assigned tasks, timelines, and priorities within NPD projects. Collaborated with project managers to ensure effective project planning, resource allocation, and progress tracking. Communicated project status, risks, and issues to stakeholders.

Shrinivas Engineering ............................................................................................................................................................... May, 2018 - May, 2019

• Designed concepts and generated G-Codes by using CATIA V5 and Mastercam respectively for optimal manufacturing of automotive specific products.

• Provided technical support to debug codes and execute manufacturing processes using organization’s standard operating procedures to produce high quality finished automobile products.

• Performed activities related to sustenance engineering/support to manufacturing assembly line including improvement of process yield, improve efficiency and reduce scrap.

• Initiated SPC methods for analyzing data to evaluate the current process and process changes. Developed new approaches to solve Critical to Quality (CTQ) problems.

• Authored manufacturing routings, Bill of Materials for lead production and minimized cycle time.

• Participated in product design and development teams and regularly presented analysis results to engineering peers and management.

• Developed and executed Engineering Change Approvals (ECA) and supporting documents needed to support changes in the manufacturing equipment.

• Improved work process and achieved 40% faster cycle times by optimizing efficiency through increased metal removal rate by Dynamic Motion Technology.

K. K. Wagh Institute of Engineering Education & Research (Internship)........................................................................ May, 2016 - May, 2018

• Designed, fabricated, and optimized – complete life cycle from concept development through installation and completion using PLM - a 125cc petrol engine manual transmission racing go-kart with enough torque to pull a vehicle weighing around 2.5 tones and with an acceleration of just under 12 m/s2 during testing phase while implementing several FEA test methods and working in a fast-paced environment.

• Demonstrated strong mechanical aptitude while leading multiple vehicle design engineering teams which aimed at design and development of the vehicle with hands-on collaboration between steering subsystem using Ackermann principles, the chassis subsystem with space grade aluminum body (AA7075-T6), the brakes, and powertrain subsystem with innovation in vacuum fuel pump design and sustainable electromechanical energy recovery system while adhering to Critical to Quality (CTQ) specification.

• Oversaw sourcing activity coordination and processes for sourcing duties relating to vehicle development including supplier selection, capability assessment, and readiness of suppliers.

• Explored potential sources of supply for purchased products to ensure prices are competitive and sufficient production capacity is available within the supply chain.

• Established and accomplished cost efficient and time effective milestones using Gantt Charts, DFMEA, and Design Validation Plan throughout project execution phase.

• Reviewed and calculated labor, material and other production costs along with reviewing schedules and future production requirements to assist management in decision making.

• Scrutinized malfunctioning parts to determine the source and solution of the problem.