Quality Engineer Technical Support

Mohammad J. Idrees

US Citizen / Pomona, CA

Cell 909-***-****: Email: ********@***.***

OBJECTIVE

To utilize my technical and interpersonal skills as a Manufacturing / Validation / Product / Electrical Test / Quality Engineer, where I can increase product quality, profitability, and customer satisfaction toward enhancing company visibility.

SUMMARY

Hands-on, Senior Engineer with extensive experience in the Medical /Semiconductor industry as a Manufacturing / Validation / Product / Electrical / Quality Engineer, which includes the following:

Prepared validation protocols including TMV, IMV, as well as IQ, OQ, PQ, PPQ, MVP, and MVR, and maintained, improved, and supported existing electrical systems or products throughout their lifecycle.

Improved the manufacturing processes and reduced waste by implementing a value stream.

Knowledgeable / experience in Process Control Plan, Design of Experiment, Layout Inspection Techniques, Lean Manufacturing, Gage R&R, DMI/DFA, PFMEA, CAPA, Capability Study, Process Flow Diagrams, root cause analysis, corrective action, value stream mapping and tested, troubleshot, repaired, and calibrated analog/digital circuits, sensor input-output board at the component level for semiconductor devices.

Continuous improvement by using Lean Manufacturing, increasing efficiency utilizing FDA, GMP, ISO 9000 and AS9100, ISO 13485 & CFR820 guidelines, and EU MDR and FDA regulations

Provided customer on-site technical support and services as required. Performed supplier’s quality process audit and helped supplier with cost and scrap reduction. Monitored, analyzed, and generated Non-Conforming Material (NCR) disposition and closure. Procurement for component obsolescence issues Create & maintain the Preferred Parts List document for approved component suppliers.

Find root cause analysis on technical issues reported by customers. FAI – first article Inspection

Quality and control of manufacturing processes and post-market performance of medical devices.

Modified and built equipment, providing technical support to customers; traveled to customer sites, domestically and overseas

EDUCATION

West Coast University, Los Angeles, CA

BS in Electrical Engineering

PROFESSIONAL EXPERIENCE

Fase Group (UKG) Martinez, California 03/2024 - Present

Provided technical support for UKG systems, addressing user issues and malfunctions.

Assisted in the installation and configuration of UKG software and modules.

TCS (Assignment with Medtronic, Louisville, CO) 07/2022 – 12/2023

Sr. Manufacturing /Test Engineer

New Product Introduction (NPI) and authoring/execution of validation protocols, Master Validation Plan/Report, and Process Map. I worked on remediating CAPA 539100 manufacturing to update the validation documents.

Ensured the smooth launch of new products on the manufacturing floor to meet customer requirements.

Prepared validation protocols/Reports, including TMV and IMV, IQ, OQ, PQ/PPQ, MVP, MVR, MSA, Validation Plan, and Process Map. Created and executed test protocols to qualify and validate manufacturing processes, analyzed results, made recommendations, and completed protocol reports, manufacturing instructions, and other controlled documentation.

Analyzed and resolved complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations) as required. Provided direction to the cross-functional team members as required.

Responsibility to support and continuously improve current manufacturing processes through technical and process innovation for manufacturing.

Abbott, Sylmar CA, 12/2020 – 05/2022

Quality Manufacturing Engineer

Experience with Gap Assessments of new medical devices. Ensured documents and products contained no errors and were properly regulated for manufacturing. Evaluated compliance with existing requirements that will be more strictly assessed in the new regulatory environment.

Investigated tested troubleshooting and resolved quality-related issues (including customer complaints) in collaboration with other departments by applying various techniques for problem-solving, such as cause-and-effect diagrams, 8D, Kaizen, DMAIC, and 5 WHY. SOPs, inspection checklists, and other quality control documents need to be created, implemented, and improved as needed.

Created and maintained drawings, BOMs, and Gap Assessment Documents for existing and new products (Pacemaker, Pacing Leads, ICD (Implantable Cardioverter Defibrillator), and External Patient Activator.

Ensured new products were smoothly launched to the manufacturing floor to meet customer requirements.

Validation protocols for new product development and provided technical support to manufacturing for Pacemaker, Pacing Leads, ICD (Implantable Cardioverter Defibrillator), and External Patient Activator.

Medtronic, Culver City CA 10/2018 - 06/2020

Sr. Manufacturing / Validation Engineer

Remediation experience in medical devices: Assessed previously completed validations, processes, or design changes. Executed remediation validation/verification activities: IQ, OQ, PQ/ PPQ, MSA, TMV, IMV, as well as Validation Plan and Process Map. Improved the manufacturing processes and reduced waste through the implementation of a value stream.

Validation protocols for new products and providing technical support to manufacturing for catheter products and catheter assembly process technologies.

Line support - Building development/R&D builds, validation units. Daily manufacturing floor support. Provided technical leadership for the projects. Led and coordinated activities of engineers and technicians/operators in support of process and equipment development/qualification (including tooling), process troubleshooting, and custom equipment procurement. Procurement for component obsolescence issues.

Created and maintained Drawings, BOMs, and Documents for new and existing products.

Troubleshooting and problem-solving manufacturing lines and equipment. Ability to train operators.

Root Cause Analysis. Participated in the resolution of Non-Conformances and Corrective and Preventive Actions.

Provided direction to the cross-functional team members as required.

EMI, Santa Ana, CA 01/2018 – 10/2018

Manufacturing / Quality Engineer

New Product Introduction (NPI) and authoring/execution of validation protocols. Ensured new products were launched to the manufacturing floor smoothly to meet customer requirements.

Responsible for Surface Mount Technology, manual inserting components/parts of the bare board, soldering, inspection, completing the top level, PCBA, or bard board, and moving to the next level of operation/manufacturing.

Responsible for implementing and generating work instructions or Flow Charts from Bills of Materials, assembly drawings, or build packages and can understand detailed instructions with minimal supervision.

Developed and implemented production traveler steps by AS9100 and ISO9001

SMT-based assemblies. Developed PCBA process and assembly instructions and documentation to support products released to manufacturing for both ROHS and non-ROHS processes.

Edwards Lifesciences, Irvine CA 07/2015 - 03/2017

Manufacturing / Validation Engineer

New Product Introduction (NPI) and authoring/execution of validation protocols. Provided technical support to technicians for atrial fibrillation (Catheter Products) and Heart valve.

Created and maintained Drawings, BOMS, and Documents for the existing and new products.

Prepared and reviewed validation protocols / Test Method Validation protocols and final reports, TMV, IMV, (IQ, OQ, and PQ). Managed product testing against approved protocols.

Tested and troubleshot various electronic circuits & equipment malfunctions. Procurement for component obsolescence issues Create & maintain Preferred Parts List document for approved component suppliers.

Supported daily manufacturing and daily operations to meet customer requirements.

Interfaced with R&D, manufacturing, clinical affairs, quality, and regulatory personnel to ensure compliance with internal and external policies, procedures, and FDA regulations.

Improved product and process design by writing engineering change notifications (ECN, ECR & CAPA).

Knowledgeable / experience in the Design of Experiments, Lean Manufacturing, 6 Sigma, 5S, Gage R&R, DMI/DFA, PFMEA, CAPA, Capability Study, Process Flow Diagrams, root cause analysis, value stream mapping.

St Jude Medical, Irvine, CA 09/2012- 05/2015

Sr. Manufacturing / Quality Engineer

Reviewed and developed manufacturing documents (MP, Routers, BOM, etc.)

Drafted and executed validation of product, equipment, and processes.

Interfaced with other departments to solve production problems. Provided technical support to technicians for atrial fibrillation (Catheter Products) Tested and troubleshot digital analog circuits and electronic test instruments.

Prepared pilot and validation reports, BOMs, component drawings, and manufacturing procedures.

Biosense Webster (J&J), Irwindale, CA Validation Test Engineer / Manufacturing Engineer 05/2010 - 07/2012

Prepared pilot and validation reports, and validated BOMs, drawings, and procedures.

Interfaced with R&D, manufacturing, clinical affairs, quality, and regulatory personnel to ensure compliance with internal and external policies, procedures, and FDA regulations.

Prepared and reviewed validation protocols and final reports (IQ, OQ, and PQ). Developed and revised standard operating procedures (SOPs). Coordinated the approval of quality plans and protocols.

Improved product design by writing Engineering Change Notifications (ECN, ECO & CAPA).

Maintained calibration and NCR records for internal and ISO audits.

Monitored, analyzed, and generated Non-Conforming Material (NCR) disposition and closure.

THALES AVIONICS INC. IRVINE, CA. 2/2006 to 11/2009

Sr. Product Engineer /Manufacturing Engineer

AVIZA TECH INC /ASML THERMAL DIVISION, Scotts Valley/Orange, CA 5/1993 to 1/2006

Sr. Manufacturing Engineer/Electrical Engineer

Tested, troubleshot, repaired, and calibrated analog and digital circuits at the component level for semiconductor devices including processer, analog and digital input/ outboard, temperature, and sensor board.

Installed and tested large systems upon completion; trained field service personnel.

Interfaced with engineering and implemented test procedures to assure customer compliance.

Tested semiconductor Vertical Thermal and Advanced 300 mm Thermal Reactors in a clean room environment; troubleshot wafer handling robotics and thermal control system.

Interfaced with engineering and implemented test procedures to assure customer compliance.

Corrected design errors and documented changes. Validation protocols and final reports (IQ, OQ, and PQ) Installed and tested large systems upon completion; trained field service personnel.

Modified and built equipment, providing technical support to customers; traveling to customer sites, domestically and overseas

SKILLS, TRAINING AND ACHIEVEMENTS

Microsoft Office (PowerPoint, Excel, Word)

AutoCAD / Visio, LabView, Minitab, MATLAB, SolidWorks, SAP, EPIQ, EPICOR ERP, Agile and Windchill

Frequency Generators, Oscilloscopes, DVM, Analyzers and Meters

Member of the Failure Review Board (FRB), MRB, and FRACAS teams

Certified Six Sigma Specialist. Certified in ESD, Electrical Safety, and Clean Room Practices

Certified in Lean, 5S and Kaizen team. Identify opportunities to improve Electrical Manufacturing Engineering practices and implement them as required.

AFFILIATIONS AND INTERESTS

American Society of Electrical Engineers (ASEE)

PERSONAL

Dedicated, team player, trustworthy, diversified, and global vision.

Contact this candidate