Bhavna Makhija

Senior Industrial Engineer at Boston Scientific

acci63@r.postjobfree.com

Summary

• 5 years of extensive experience in Manufacturing and Distribution Center applying Lean, Production

Planning, Production Supervision, Process Validations and Project Management.

• Core competencies include Lean Six Sigma implementation and driving Lean Transformations.

• Class III Medical device manufacturing experience, including ISO and FDA regulations.

• Master of Science (MS) in Industrial Engineering from University of Illinois, Chicago (GPA : 3.8/4:0).

• Self-motivated with strong problem solving and analytical skills, demonstrated leadership abilities,

and excellent communication skills.

Industry Skills:

• Manufacturing Skills: Process Improvements, Manufacturing Line Flow Analysis, Production Planning,

Process Validations, Staffing and Capacity Analysis, Production Supervision

• Lean Expertise: 5S, Kaizen, Poke-Yoke, Value Stream Mapping, Time and Motion Study, Just-in-Time

(JIT) and Kanban, Total Productive Maintenance, Andon, 7 Wastes

• Six Sigma and Quality Tools: DMAIC, Root Cause Analysis (5 Whys, Cause and Effect Diagram),

Statistical Process Control (SPC), Failure Mode Effect Analysis (FMEA), Nonconforming Event and

Prevention (NCEP), Corrective Action and Preventive Action (CAPA)

• Medical Device Regulations: ISO 13485:2003, FDA Quality System Regulation 21 CFR Part 820, Current

Good Manufacturing Practices (cGMP).

• Computational Skills : MRP & ERP (SAP), Minitab, AutoCAD, ARENA Simulation Software,

MS-Access, MS-Project, MS-Visio, MS-Office Suite.

Experience

Senior Industrial Engineer at Boston Scientific

September 2013 - Present (6 months)

• Driving the Site Lean Transformation Initiative by promoting Lean, applying Lean and sustaining the Lean

Culture across the entire site.

• Participated in a cross-functional Kaizen Event resulting in identifying improvement opportunities targeted

at delivering huge savings.

• Designed the Lean Collaboration Center, conducive for implementing Kaizen Events, Improvement

projects, Lean Training and Workshops.

Page1

• Responsible for establishing Process FMEAs as part of Risk Management documentation.

• Provide engineering support for High Variability, Volume and Mix Distribution Center.

• Participate in Corrective Action Preventive Action (CAPA) related activities including CAPA ownership.

• Site Lean Lead conducting Lean Training Programs for employees at all levels of the organization

Industrial Engineer, II at Boston Scientific

March 2010 - August 2013 (3 years 6 months)

• Led the production planning, scheduling and site performance reporting in order to achieve product

inventory goals, build plan and product shelf life goals.

• Investigated root cause of nonconformances, executed nonconformance dispositions and corrective

actions to improve product quality and reduce scrap rate.

• Successfully completed Green Belt Six Sigma Project, thus resulting in increased machine availability for

production by 22.5%.

• Led Lean workshops, which resulted in identifying and organizing 8 projects to improve quality, reduce cost

and minimize non-value added activity.

• Conceptualized and created production capacity models including labor, equipment and space.

• Developed, maintained and controlled production documentation including SOP’s (Standard Operating

Procedures) and traceability records.

• Supported the FDA Pre-Approval Inspection and Audit preparation by working on action items.

• Re-designed and developed the manufacturing floor layout, achieving one-piece flow, line balancing and

visual management.

• Created, qualified and implemented a procedure for scanning quality records along with performing

equipment validation.

• Additionally worked as the acting Production Supervisor while fulfilling Industrial Engineering

responsibilities.

Production Supervisor Responsibilities

• Supervised and led a team of 25+ Product Builders to help achieve operational goals.

• Managed daily activities to ensure safe, effective and efficient production of quality products.

• Collaborated with cross-functional teams to resolve production issues.

• Achieved production plans by scheduling and assigning personnel, establishing priorities, monitoring

progress and reporting production summary to management.

• Met quality objectives by ensuring compliance to quality, safety and Good Manufacturing Practices.

1 recommendation available upon request

Lean Manufacturing Intern at Motorola

May 2009 - August 2009 (4 months)

• Led and participated in Kaizen events, impacting key metrics like cost, quality and scrap reduction.

• Assisted in the implementation of Poke-Yoke, thus achieving 100% process improvement.

• Created a Value Stream Map for product line, thus reducing the product cycle time.

• Performed time and motion studies to obtain a balanced product line flow.

• Implemented various lean techniques to achieve continuous improvement.

Page2

Industrial Engineering Intern at Rockwell Automation

June 2008 - August 2008 (3 months)

• Conducted Cost-Benefit Analysis for components, achieving floor space and scrap savings.

• Created SOP’s (Standard Operating Procedure) to provide repeatable and consistent process results.

• Assisted in a pilot build by working on BOM (Bill of Materials), parts identification and procurement.

• Worked in an integrated ERP environment with extensive utilization of SAP.

• Collaborated with cross-functional teams in support of new product development.

Skills & Expertise

Six Sigma

Lean Manufacturing

Product Development

Kaizen

Data Analysis

Continuous Improvement

Manufacturing

Cross-functional Team Leadership

Supply Chain Management

ERP

JIT

Time Study

Minitab

DMAIC

Access

Quality Control

SPC

Design of Experiments

FMEA

Root Cause Analysis

Solidworks

Manufacturing Engineering

Industrial Engineering

Matlab

Value Stream Mapping

Process Improvement

Engineering

Quality System

ISO 13485

Project Management

Process Engineering

Medical Devices

ISO

Toyota Production System

Software Documentation

Poka Yoke

Supplier Quality

Page3

Assembly Lines

Kanban

CAPA

5S

MS Project

FDA

Manufacturing Operations Management

Production Planning

GMP

KPI Reports

Line Management Experience

Production Activity Control

MRP

Education

University of Illinois at Chicago

Master of Science, Industrial Engineering, 2007 - 2009

Activities and Societies: Member - IIE (Institute of Industrial Engineers)

Member - Student Leadership Development and Volunteer Services

Member - IGSA (Indian Graduate Student Association)

University of Mumbai

Bachelors, Instrumentation Engineering, 2003 - 2007

Activities and Societies: Membership and Publicity Officer - IEEE (Institute of Electronics and Electrical

Engineers)

Member - ISA (International Society of Automation)

Cultural Secretary (2005-06)

Page4

Bhavna Makhija

Senior Industrial Engineer at Boston Scientific

acci63@r.postjobfree.com

1 person has recommended Bhavna

"I had the pleasure of working with Bhavna at Cameron Health / Boston Scientific. At the time, Bhavna was

an Industrial Engineer while I was Director of Operations. Bhavna's responsibilities included traditional

industrial engineering tasks - time studies, production flow, operator training, etc. However, what set Bhavna

apart was her desire and commitment to add value to the organization however she could. Bhavna worked on

several projects outside of her scope of responsibilities within operations as an individual contributor and as a

project lead. She always delivered at a high level, kept management involved, and set high standards for her

peers to follow. In addition, Bhavna has a great attitude and is very enjoyable to work with. She is always

positive, takes input well, and provides relevant feedback to her peers and management as needed. I highly

recommend Bhavna and wish here well in her future pursuits. John Robertson"

John Robertson, Director Of Operations, Cameron Health, managed Bhavna at Boston Scientific

Contact Bhavna on LinkedIn

Page5

Contact this candidate