Gokulakrishnan Muniyandi
Lowell,Massachusetts
Summary
Accomplished and detail-oriented Principal Quality Engineer with over six years of progressive experience in supplier quality, regulatory compliance, and cross-functional project leadership within the medical device industry. Demonstrates deep expertise in quality systems, risk management, and supplier development across cardiovascular, neurovascular, and renal care domains. Recognized for driving strategic initiatives, mentoring technical teams, and leading complex qualification programs that align with business objectives. Adept at optimizing
processes, and delivering high-impact solutions that enhance product quality and operational efficiency.
Overview
10
10
years of professional experience
6
6
Certifications
Work History
Principal Quality Engineer/Supplier Quality Engineer
Medtronic Inc
Lowell, Massachusetts
12.2024 - Current
- Led PPAP, PFMEA, Control Plan, and Lot Verification Plan activities to support manufacturing transfer and production ramp‑up readiness for critical components and processes.
- Supported early Quality assessments for manufacturing transfer by evaluating PPAP maturity, process capability, inspection strategies, and validation readiness.
- Provided risk‑based Quality inputs to cross‑functional teams to inform manufacturing transfer planning, sequencing, and mitigation strategies.
- Partnered with Engineering, Manufacturing, Supply Chain, and Operations to identify and close Quality readiness gaps impacting transfer timelines.
- Implemented risk‑based inspection strategies, including Supplier Owned Quality (SOQ) models, to stabilize quality and reduce inspection burden during post‑transfer production.
- Contributed Quality risk inputs and mitigation considerations in cross‑functional reviews supporting Supplier Quality activities and manufacturing readiness.
- Served as Affera SQE site lead for contract associates, acting as the primary Quality contact for project managers, suppliers, and site leadership.
- Provided technical guidance to Quality Engineers on PPAP strategy, Lot Verification Plans, and risk‑based inspection approaches during manufacturing ramp‑up and transfer activities.
- Led targeted initiatives to improve efficiency and explore AI‑enabled solutions, including development of an automated PPAP tool (PPAPrika) that reduced PPAP cycle time and cost.
- Supported regulatory and quality system readiness by acting as a subject matter resource during audits and inspections (TUV, FDA).
Senior Supplier Quality Engineer
Medtronic Inc
Lowell, Massachusetts
12.2022 - 12.2024
- Developed and implemented an inspection plan that reduced inspection time for the critical part PRT-00241 from over six weeks to four days.
- Designed and executed a Supplier-Owned Quality (SOQ) process that further reduced inspection timelines to two days.
- Coaches and reviews the work of lower-level specialists on Supplier ASL activities, Quality Impact Assessment, and NPD activities.
- Responsible for the entire Quality Impact Assessment processes within the project for multiple components.
- Individual Contributor for PPAP, Component Qualification, Quality Impact Assessment, Approved Supplier List, and Supplier Training.
- Led in the creation of a component qualification plan for components and qualified suppliers.
- Handling multiple projects across various areas, like Cardiovascular, Neurovascular, Peripheral Vascular Health, and Renal Care.
Supplier Quality Engineer II
Medtronic Inc
Los Angeles, California
01.2022 - 12.2022
- Created a product, service, and feature-level quality impact assessment for components and suppliers.
- Created and led supplier approval records, including approving suppliers, supplier segmentation, and supplier survey.
- Worked on and developed the Supplier-Owned Quality (SOQ) process for both contract manufacturers and component suppliers.
- Worked on and led the creation of the Supplier Product and Service Qualification Master Plan for Contract Manufacturers.
- Developed Manufacturing Process Instruction, Inspection Instruction.
Worked on PFMEA, DFMEA, MVP, Supplier Control Plan, ABIs, PPM, Process Capability analysis, DoE, SPC, and BOMs. - Worked with cross-functional teams in evaluating and qualifying suppliers for the product.
Supplier Quality Engineer (Contractor)
Vastek Inc Client: Medtronic Inc
Sunnyvale, California
09.2019 - 01.2022
- Worked as SQE for MDT(Medtronic) CVG's newest acquisition in premarket.
- Developed and reviewed FAI reports and inspection reports for new product development (NPD).
- Worked on various New Products.
- Supported FDA Audit and PMA release for Launching product in Europe and United States.
- Led creation of 100 Indirect Material specifications.
- Led work to create a component control plan for components.
- Implemented and guided design changes for components.
- Created and implemented a sampling plan for incoming inspection.
- Created NCMRs, Developed Test Method and Test Method Validation.
Programmer Analyst
Cognizant Technology Solutions Ltd
Chennai, TamilNadu
09.2016 - 07.2017
- Worked in a project under Health Care domain.
- Developed source code for Claiming of Medical Insurance.
- Worked on Back-end, and Front-end on generating Bill of Materials.
- Worked on Testing source codes for errors.
- Developed Codes using SQL.
Assisted and Led the team towards completion of projects. - Trained in FACETS and Worked with Database using Oracle PL-SQL.
Education
Master of Science - Industrial Engineering
New Jersey Institute of Technology
Newark, New Jersey, NJ05-2019
Bachelor of Science - Mechanical Engineering
SRM University
Chennai, TamilNadu, India05-2016
Skills
- Leadership
- Time management
- Communication
- Team player
- prioritization
- Minitab
- AutoCAD
- Process analysis
- SolidWorks
- Lean manufacturing
- Process validation
- PFMEA
- Operations management
- Project management
- Continuous improvement
- Microsoft Office
- Supplier qualification
- Quality impact assessment
- Coaching and mentoring
- Problem solving
- Risk assessment
- Critical thinking
- Root cause identification
- Process capability analysis
- PPAP submissions
- Engineering support
- Non-conforming materials report
- Inspection planning
- Microsoft Power Apps
Certification
Certified Auditor/Team Lead
Timeline
Principal Quality Engineer/Supplier Quality Engineer
Medtronic Inc
12.2024 - Current
Senior Supplier Quality Engineer
Medtronic Inc
12.2022 - 12.2024
Supplier Quality Engineer II
Medtronic Inc
01.2022 - 12.2022
Supplier Quality Engineer (Contractor)
Vastek Inc Client: Medtronic Inc
09.2019 - 01.2022
Programmer Analyst
Cognizant Technology Solutions Ltd
09.2016 - 07.2017
Master of Science - Industrial Engineering
New Jersey Institute of Technology
Bachelor of Science - Mechanical Engineering
SRM University