MADHU SAGIRAJU
Monument,CO
Summary
Dynamic Project Engineer with expertise in the healthcare device industry, skilled in ISO compliance and process validation. At Jabil Inc., I successfully led cross-functional teams to enhance manufacturing processes and improve product quality. Proficient in SAP & MES Tools, I excel in problem-solving and risk assessment, driving impactful results in complex projects.
Overview
8
8
years of professional experience
Work History
PROJECT ENGINEER- MES SUPPORT
JABIL INC. -CONTRACT:TATA CONSULTANCY SERVICES LTD
01.2024 - Current
- Participated in MES Design Quality workshops & Gap Refinement for all topics covering the entire scope of MES and eco-system.
- Participated in weekly sessions of continuous testing system of learning all scope & eco system including self-learning activities.
- Participated in sessions to learn how to configure the system and create data in MES.
- Supported Business PM to define the cutover strategy for ramp-up in six months and collect the required data to verify relevancy.
- Prepared Data & Configuration for Quality & Production Environment.
- Acted as owner of data creation and configuration for SKU's and Routers in scope.
- Supported configuration for equipment connectivity.
- Executed BDT & UAT scripts in classroom sessions.
- Participated in GAP Demo Sessions & Learned MES Technical Troubleshooting.
- Reviewed GAP demo sessions.
- Performed Go-Live & Ramp-up Support including procedure updates for defects.
PROJECT ENGINEER- EU MDR SUPPORT
JABIL INC- CONTRACT TATA CONSULTANCY SERVICES LTD
04.2021 - 12.2023
- Created a New Manufacturing Process Data (MPD) document which relates to the overall plant product manufacturing process flows and gathered all contact materials and water contact steps for every operation.
- Reviewing and Approving MPIs (Manufacturing Process Information documents) according to the SOP's and all the work instructions.
- Worked on Class Ir Project, which is another part of MDR compliance, which requires updating all the EU parts related drawings, Process sheets and Inspection sheets using CREO CAD tools and Windchill to update the routers etc.
- Provided support for trainings, change request and change notice workflow process to all the Mfg. & quality engineering team.
- Worked with Suppliers to document Process Flow Charts, PFMEAs.
- Revised and updated Labeling and Packaging Standard Operating Procedures.
- Set up whole new Material master data, Routers, BOMS, Production versions, Inspection types & classifications for the brand-new parts in the SAP system.
- Performed Multiple Non-Sealable process tests for the new labeling printing systems (Ex: New Implant card label for MDR).
- Added brand new labels (ICL, MRA) and process instruction to perform in the packaging areas to comply with new EU MDR Regulations.
PROJECT ENGINEER
JABIL INC- CONTRACT TATA CONSULTANCY SERVICES LTD
04.2019 - 03.2021
- Supported packaging team on Projects (eg: Rubik) which aligned packaging portfolio globally with standardized packaging configurations and branding and removed shrink wrap, Scan in & Scan out operation for all the Production routers.
- Supported Clip Pack II, RIA II, SRS, NGP etc. by creating change request acting as a change owner using Windchill application.
- Executed cross validations IQ/PQ for the existing machines in screw/finishing areas to perform/operate multiple part families to increase the production.
- Created new inspection sheets for NPI parts in the BabtecQ Inspection system.
- Consolidated and drafted shipping process sheets
PROCESS ENGINEER
TERUMO BCT- CONTRACT FUSION LIFE SCIENCE
04.2018 - 03.2019
- Provided guidance on the development of verification and validation plans, test and sampling methods, sample size determination and acceptance criteria.
- Extensive experience on Test Method Validation (TMV) for analytical, attribute and variable measurements.
- Designed test fixtures using Solid works, developed test methods, and executed Gage R&R methods.
- · Conducted product testing, creates models, and prototypes, and provided constructive feedback to design engineers.
- Conducted project management tasks & documentation with design controls and risk analysis in accordance with established SOPs.
- Incorporated required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the design history file.
- Expertise in statistical analysis methods like Crossed GR&R, Nested GR&R, attribute agreement analysis using Minitab.
- Developed and/or reviewed Process Qualifications, Test Method Validations, Gage R&Rs, Process Capability studies, DOE, DHF, DHR, Design V&V, FMEA and PFMEA.
- Provided specification and design of HVAC, plumbing, and fire protection systems for selected architectural projects within defined budgets.
- Designed Test fixtures using Solid works, Developed Test methods and executed Gage R&R methods.
SYSTEM ANALYST
SAGGI SOLUTIONS, INC.
09.2017 - 04.2018
- Managed and maintained daily system processes as well as documented processing requirements and system functions.
- Analyzed data, System design, Test program development, Logic process flows and Specifications.
- Supported Full vendor management functions including selection, Onboarding and Ongoing management.
- Produced reports as needed for research, Error resolutions and stakeholder requirements.
- Co-ordinated and implemented Software, hardware, and Firmware updates for core system.
- Promoted efficient operations through the creation of workflow, reports, job schedule and macros.
Education
Master of Science - Industrial Management
University of Central Missouri
Warrensburg, MO05-2017
Bachelor of Technology - Mechanical Engineering
Andhra University
INDIA05-2014
Skills
- Healthcare Device Industry Expertise
- ISO 13485, 21 CFR Part 820, ISO 14971, 21 CFR Part 11 and HIPAA Privacy
- Non Conformances (NC) &Corrective and Preventive Actions (CAPA)
- CREO Parametric Proficiency
- Process Validation
- Risk Assessment Expertise
- Problem-Solving Technique
- SAP Proficiency
- People management
- Cross-functional team collaboration
Languages
English
Full Professional
Telugu
Native or Bilingual
Timeline
PROJECT ENGINEER- MES SUPPORT
JABIL INC. -CONTRACT:TATA CONSULTANCY SERVICES LTD
01.2024 - Current
PROJECT ENGINEER- EU MDR SUPPORT
JABIL INC- CONTRACT TATA CONSULTANCY SERVICES LTD
04.2021 - 12.2023
PROJECT ENGINEER
JABIL INC- CONTRACT TATA CONSULTANCY SERVICES LTD
04.2019 - 03.2021
PROCESS ENGINEER
TERUMO BCT- CONTRACT FUSION LIFE SCIENCE
04.2018 - 03.2019
SYSTEM ANALYST
SAGGI SOLUTIONS, INC.
09.2017 - 04.2018
Master of Science - Industrial Management
University of Central Missouri
Bachelor of Technology - Mechanical Engineering
Andhra University
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