Balakumar Jayakumar
Guelph,ON
Summary
To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
14
14
years of professional experience
Work History
Supplier Engineer Team Lead
Boston Scientific
09.2022 - Current
- Collaborated on interdisciplinary teams to develop creative, cost-effective solutions for complex projects.
- Reduced overall supply chain risk by identifying vulnerabilities within the supplier network and developing contingency plans.
- Achieved successful project outcomes by maintaining accurate documentation and meeting strict deadlines.
- Enhanced supplier performance by implementing strategic management processes and regular evaluations.
- Evaluated supplier proposals based on predefined criteria, ensuring the selection of best-fit partners for the organization''s needs.
- Spearheaded cost reduction initiatives through value engineering projects with select suppliers, achieving significant financial savings without compromising product quality or delivery timelines.
- Reduced inventory levels and improved supply chain visibility using strategic initiatives.
- Consolidated supplier base while maintaining redundant sources of supply to reduce transit expenses and improve timely delivery.
- Developed strong relationships with key suppliers, fostering collaboration and mutual growth opportunities.
- Coordinated cross-functional teams for effective supplier selection, ensuring alignment with company goals and requirements.
- Directed and supervised team of 5 engaged in Material Qualification and Supplier development.
Supplier Quality Team Lead
Boston Scientific
01.2021 - 09.2022
- Improved supplier quality by conducting comprehensive audits and assessments.
- Developed strong relationships with suppliers through regular communication and site visits.
- Implemented robust supplier qualification processes, ensuring consistent product quality.
- Reduced production delays by closely monitoring supplier performance and addressing issues promptly.
- Collaborated with cross-functional teams to address supplier-related concerns and implement corrective actions.
- Maintained accurate records of supplier evaluations, certifications, and performance metrics for easy reference.
- Conducted thorough risk assessments for potential new suppliers, mitigating potential issues before onboarding.
- Established clear expectations for suppliers through detailed specifications and requirements documentation.
- Identified opportunities for continuous improvement within the supply base, driving overall operational excellence.
- Monitored staff organization and suggested improvements to daily functionality.
Sr Supplier Quality Engineer
Baylis Medical
09.2019 - 01.2021
- Support new product development projects from design concept through product launch activities
- Manage Supplier approval process
- Participate/provide guidance to Engineers for Supplier audits
- Review Supplier Audit report and share it with the Supplier for response
- Investigate NCR and issue SCAR whenever needed
- Ensured the compliance with applicable FDA, ISO 13485, and international regulatory laws/standards with all deliverables
- Work closely with supplier to improve measurement methods/process that would help/prevent/optimize Baylis production
- Formulate quality agreements with all essential information pertaining to product/process that is procured from the Supplier
- Monitored and Improved Supplier Management processes as needed.
- Set up ongoing supplier site evaluation parameters to maintain quality control standards over long-term relationships.
- Provided capability assessment and testing for individuals and teams assigned by suppliers.
- Identified and defined production-critical supplier issues, providing differentiation from in process quality control discrepancies.
Supplier/ Design Quality Engineer
DePuy Synthes (HCL America INC)
03.2016 - 08.2019
- Support new product development from design concept through product launch activities
- Support design control activities for new product development efforts
- Develop risk assessments, design validations/verifications, inspection methodology, and acceptance for inspection sample plans as part of the project teams
- Ensured Risk Management procedures, processes and files are updated where required
- Develop custom gage design for identified alternate inspection method
- Execute Correlation study to identify and eliminate possible variation across Suppliers and Receiving inspection
- Streamlined improvements by participating in Risk Analysis and Change Control meetings and implementation of risk management practices (Design FMEA / Process FMEA) to product/process development lifecycle
- Analyzed and interpreted procedures, engineering blueprints, drawings using the Geometric Dimensioning & Tolerance (GD&T)
- Ensured the compliance with applicable FDA, ISO 13485, and international regulatory laws/standards
- Interact with supplier to validate any special processes that has been identified for NPD activities
- Perform and witness FAI at supplier for the initial PPAP parts
- Support supplier extensively with the PPAP process
- Manage offshore task loading for projects
- Prepare and supported in new business proposals.
Quality Control Engineer
Terumo (Verotech Solutions, LLC)
10.2015 - 03.2016
- QE responsible for the remediation of Heart Lung Machine (HLM)
- Developed Test Method Validation (TMV) Protocols and Reports for Variable and Attribute Test Methods (mechanical/non-analytical) for electrical and electronic components used in Design Verification
- Experience in creating Test Method (TM) and reports for receiving inspection, which helped the organization to train the operators and re-structure the receiving inspection department
- Lead cross functional group in conducting analysis of NCMR's/ NCR's, with the purpose of evaluating the underlying issues
- Audited quality documentation (DHR) by following FDA requirements and performed trend analysis on the raw data
- Performed GAP analysis for Product spec and Part Inspection plan documents of the legacy parts
- Reviewed and approved Critical Features Identification, Engineering Change orders, Supplier FMEA and Control Plans
- Reviewed Design FMEA and Process FMEA and assessed Risk for legacy parts to determine its criticality.
Sr. Application Engineer
Emerson Process Management
05.2010 - 07.2013
- Experienced in Project Planning and execution
- Performed SPC to analyze the variation in wedge dimensions to control the process
- Performed PPAP, MSA as per APQP as a Tier 1 supplier of valves to automotive and other process industries
- Implemented Capability studies in a cost reduction project to reduce defects in valve parts
- Applied 8D to identify the cause for the leakage of valves at the customer site
- MRO support for existing customers including parts and valve replacement and created BOM
- Experience in JDE platform in executing projects
- Experience working with Supplier for the purchase parts and deciding on the sourcing location
- Lead a team for auditing documentation as per ISO requirements.
Education
Master of Science - Industrial Engineering
Wichita State University
Wichita KS07.2015
Bachelor of Science - Mechanical Engineering
Amrita University
Coimbatore, India05.2010
Skills
- Process Improvement
- Root Cause Analysis
- Project Planning
- Quality Control
- Statistical Computing Methods
- Staff Development
- Performance Management
- Six Sigma Methodologies
- Change Management
- Root Cause Identification
- PPAP Submissions
Projects
Detection of Engine Nozzle Wear in Diesel Engine Using Vibration Signature Analysis Methods, Aimed at finding a non-intrusive detection method for fuel injector nozzle wear, Vibration signal is obtained from a diesel engine with three different nozzle conditions and running at three different speeds. Useful information is extracted from the acquired signals using data mining techniques and is used for developing a classifier that could classify future data Standardizing the variation of coffee by weight at Starbucks - Wichita State University, A DMAIC study was undertaken to improve the existing process at Starbucks, Focus was on standardizing the quantity of the coffee. SPC, MSA were used in the process of determining variation. Developed a KANO model to identify customer requirements
Timeline
Supplier Engineer Team Lead
Boston Scientific
09.2022 - Current
Supplier Quality Team Lead
Boston Scientific
01.2021 - 09.2022
Sr Supplier Quality Engineer
Baylis Medical
09.2019 - 01.2021
Supplier/ Design Quality Engineer
DePuy Synthes (HCL America INC)
03.2016 - 08.2019
Quality Control Engineer
Terumo (Verotech Solutions, LLC)
10.2015 - 03.2016
Sr. Application Engineer
Emerson Process Management
05.2010 - 07.2013
Master of Science - Industrial Engineering
Wichita State University
Bachelor of Science - Mechanical Engineering
Amrita University
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