Enthusiastic Engineer experienced in quality, process development, tooling, regulatory compliance, and operations with a focus on building cross-functional teams, driving robust process development, and continuous improvement projects helping drive the company's growth and strategic objectives through Operational Excellence and genuine customer service.
Overview
8
8
years of professional experience
Work History
Senior Process Development Engineer
Boston Scientific
09.2022 - Current
Supporting TDP and PDP projects
Worked with Operations Team to Characterize and Address various Stent Dimensional defects.
Working the Operations Team to improve productivity of Nitonol Electropolishing manufacturing lines.
Provided guidance and support ME team on trouble shooting processing issues NSM(Nitinol Shape Memory) manufacturing lines.
Worked on VIP project for Stents to increase productivity.
Deep dived into Electrochemistry/Electropolishing process, conducted various feasibility study experiments to understand parameters for Electropolishing in sulphuric Acid bath.
Investigated on Hydrophilic coating failure on Rubicon Control Catheters, owned and conducted experiments to help pass FDA approval.
Working on NPD project , Ranger Radial Project on various PDP activities , Test Method Validation, Process validation activities( OQ, PQ), PVD updates and PRA(risk analysis) working closely with ME's and Operations Team.
MANUFACTURING ENGINEER
Advanced Molding Technologies LLC
01.2019 - 09.2022
Responsible for the smooth running of manufacturing lines for various injection molded medical and automotive parts.
Guided and mentored summer interns on engineering and quality improvement projects.
Trained in Scientific Molding Process.
Calculate and improved OEE for injection molding presses by downtime analysis and Pareto charting press issues.
Driving CIPs for various customer product lines including secondary operations.
Created a Lean manufacturing implementation roadmap for management.
Worked on creating the QATS (Quality at Source) program road map, project charter and presented to management.
Active Member of the Operational excellence steering team and Manufacturers Alliance Peer group
Work closely with Project Engineers and process techs during process development (IQ, OQ, and PQ) to identify potential tooling and processing issues and offer input.
Work closely with Quality Engineers in protocol development and execution for qualifying processes/steel change or spare component qualification.
Worked on a project to optimize the cooling time in injection molds by improving the heat transfer rate
Using Minitab to generate ANOVA, correlation and regression, Hypothesis tests and confidence intervals, Control charts, process capability, Statistical Analysis, and measurement system analysis.
Closely worked with VP of Operation in launching and creating the Idea Generation board and system
Knowledge of FDA/QSR requirement & quality systems in Pharma and/or medical device experience required (i.e 21 CFR Part 820, Quality System Regulations and ISO 13485 requirements)
Worked on Project to optimize the NCR/CAPA system and Corrective action effectiveness by introducing a Risk-Based approach to evaluating NCRs and helped reduce CAPA throughput by 25%.
Responsible for managing the CAPA program: leading cross-functional teams, using systematic problem-solving methodologies like fishbone/Ishikawa diagram, 3 legged 5why, DOE, etc, and updating company and customer management in weekly meetings
Conducted SPC and statistics for quality training for engineers and QC lab techs
Conducted Lean Manufacturing Training for Advanced Molding Technology employees
Worked on the groundwork for SPC implementation
Worked on creating EOAT (End of Arm Tools) for new projects
Managed LTPD(Lot Tolerance Percent Defective) sampling for finished lots for medical device customers
QUALITY ENGINEER/ PROCESS IMPROVEMENT ENGINEER
ELECTRIC WIRE PRODUCTS CORP
10.2017 - 01.2019
Lead process improvement for all the wire harness manufacturing
departments
Reduced setup time on Wire cutting machines as a part of the SMED
project
Changed layout of tube cutting area and layout to improve the flow of
materials as part of the 5s project
Mentoring and coaching employees on continuous improvement, Lean, and
Lean Six Sigma
Carried out Pareto analysis on assembly errors to focus improvements on
the Terminating, splicing, and molding department
Created SOP for wire cutting machines by shadowing operator and working
with department supervisor
Created visual aid and debottlenecked splicing work station by
implementing one-piece flow
Reduced splicing errors by 80% at the splicing work station by figuring out
optimal steps to complete the process and use of visual aid
Developing and submitting PPAP documents for new product launches to
meet customer requirements
Maintaining Control Plans, Process flow diagram and Improving PFMEA's
throughout the life of the part
Assisting in maintaining compliance with ISO 9001: 2015.
MECHANICAL/INDUSTRIAL ENGINEERING INTERN
ABSOLUTE QUALITY /STARK ELECTRONICS
06.2017 - 08.2017
Created a process flow diagram to assess the current health of the wire
cutting side of the manufacturing floor
Drew spaghetti diagrams for each process to track operator, material and
information flow during
Worked closely with the supervisor and plant manager in evaluating
alternative floor plans for improving the flow of material and minimizing the
movement of personnel
Conducted waste walks and documented findings for future continuous
improvement projects
Presented findings to company owners on the current state of affairs and
suggested road map for process improvements
Worked on standardizing work on all the automatic wire cutting machines
Used AutoCAD LT to draw a new manufacturing floor plan to improve the
flow of the process
Calculated footprints for the wire cutting and stripping machines on the
floor.
TRAINEE MANUFACTURING ENGINEER
BULLETTOOLS
08.2016 - 04.2017
Worked on the MATO belt lacer prototype, performed root cause analysis
and suggested design changes and thereby improving the efficiency of belt
lacing to 90%
Optimized CNC programs for the parts run on HAAS CNC mill and reduced
cycle time by 5 mins
Performed Stress calculations on the PFC cutter machine to determine the
shear pin size
Performed heat transfer calculations on the Auto welder fixture to
determine the depth of the seat
Conducted weekly 5S training sessions for assembly and shop floor
workers
Initiated RED TAG project and set up a RED TAG log on file maker
database
Programmed the Arduino board in C++ for raptor machine (cement fiber
shear machine)
Created a spreadsheet model for machining speeds and feeds
Assisted in product development including product testing and analysis,
supplementary drafting, and new product Re-design for Manufacturability
Trained in File maker pro 15.0 and created a database for the Standard
operating procedures
Senior Therapy Development Specialist at Boston Scientific (acquired Silk Road Medical) January 2025Senior Therapy Development Specialist at Boston Scientific (acquired Silk Road Medical) January 2025