Supply Chain Project Management

****.*******@*****.*** Union City, CA ***** USA 415-***-**** Omid Tehrani

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Summary

+20 years of accumulated knowledge in project management, process control, systems integration, manufacturing, quality management, and reliability engineering. Practiced in performing an array of complex technology transfer, HVM enablement, SOP development, Cpk improvement, supply chain quality and cost engineering. Systematic problem solving and core-team building. Experienced lean 6-sigma practitioner with a broad comprehension of the value chain yield optimization in xGMP ecosystem. Qualification

+15 years of supplier EVQ experience in semiconductor, medical equipment/devices, pharmaceuticals, and automotive manufacturing, within multiple geographies delivering all aspects of QA function review in line with the QMS and policies.

Collaborative FMEA, QRM, RA, SCAR, MRB, PQP planning and implementation. Supply chain QS requirements and CoQ optimization, Document control, with focus in NPI, ramp and sustaining phases of PLC, from R&D, to HVM MFG and sustaining the required QAN.

Team development and group leadership with a focused approach to problem solving to handle complexity and structuring the 3rd-party SLA terms, aligned with company’s quality goals. Interacting with stakeholders in different capacities and disciplines. Ability to form a cohesive framework for information transfer from SQN to QYR team. Experience Project Manager, FESTO Corp., Livermore, CA (March 2023 – Present)

Provide the full aspect of project management in manufacturing semiconductor manufacturing equipment control and automation solutions, as well as medical equipment and other industries including material handling systems. The responsibilities include carrying projects from early concepts through manufacturing, while lending technical guidance and leadership for projects including criticality, scheduling, budgeting, quality, and stakeholder reporting of project statuses.

Utilizing SAP ME, structured the project from R&D to transitioning to HVM for setting up scheduling, operation steps, material staging, and documentation revision control. Internal resources coordination and supplier documentation audits. Controlling project scopes and performing technical feasibility analysis, for resource availability and allocation. Developing detailed project plan and progress tracker. Process verification and change management changes. Monitoring project performance control, structuring and managing BOM in SAP for NRE, Prototype and Production phases. Performing risk management and documentation control. Organizing and Authoring FAI reports consist of QC, Functional Test, IR Test, Certificate of Conformity, Labeling, BOM/ Electrical/ Mechanical/ Material audits.

Overseeing RMA requests dispositioning process, ensuring required resolution steps are documented, and the RMA cases in the QAN system are closed. Reporting and analysis of DMR / NCMR requests submitted by the semiconductor client for products NC parts, through designated portal or direct communication. Responsible for multilevel RCA for returned products to identify failure modes, initiating and implementing CAPA / CPI. Implementing lessons learned from RMAs in design and manufacturing processes enhancing product reliability and CSI.

MDM responsibilities include managing and controlling BOM from concept development to sustaining and EOL throughout the product/project life cycle. Overseeing multi-level BOM creation as a PM for the R&D department and development of the Engineering into Manufacturing MBOM and Sales SBOM. In the component/systems development field, working closely with stakeholders, developing Production, Config, Assembly, and SW BOMs required by control systems development. Owned program-level audit trail and revision/change control management as an essential part of the document records.

Collaborated with operations planning in devising Master Plan align with the high-level strategic objectives of EPG program as a roadmap, providing direction and setting the scope of work. The Master Plan for HVM @ Mason, OH, identifies projects key milestones, resources, and dependencies and establishes timeline for the project, as well as risks, budget considerations, and stakeholder engagement. Set up and monitored Master Schedule for the tasks outlined in the Master Plan as a tactical framework for day-to-day execution. Validation Specialist / Quality Engineer, Roche-Genentech Corp., S. San Francisco, CA (Sep 2022 – March 2023)

Supporting Equipment Qualification Lifecycle (Design, Instrumental, Operational, Performance, and Decommissioning per QA approved protocols). Collaborating with Quality stakeholders to ensure timely release of GMP equipment for validation/testing. Coordinating EQ

(OQ-IQ-PQ) and PM ARs. Teaming up with SME engagements to provide technical assessment, URS, and review data generated. Ensuring equipment and systems validation states, periodic PM logs and documentation audits. Worked with the Manufacturing Systems department in implementation of the MES along with SCM, testing ERP, auditing SPM, and analytics.

As a Change Control Owner for EQ and production activities related to the IMP QCS strategy, performing internal and external audits, and participating in QC discrepancy assessments, investigations, method validation support. Training EQ members on Equipment Qualification Lifecycle requirements and adherence to cGMP compliance, for the Agilent supplied feed forward HPLC DMS solution. Optical Systems Quality Engineer, KeySight Corp., Santa Clara, CA (April 2022 – Sep 2022)

In a joint development project (KeySight Corp – ASML Corp) responsible for precision optical components NTI quality assessment. Provided direction and content in Laser Interferometry (FFI) WF Quality Inspection SOP and metrology requirements ensuring the quality of the ****.*******@*****.*** Union City, CA 94587 USA 415-***-**** Omid Tehrani

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optical system final assembly. Drove improve activities for optical component manufacturing, fabricating best-in-class products in quality and functionality. Performed verification for the system accuracy at final assembly, as well as supporting process and product development.

Assessed optical metrology equipment (i.e. WYCO, ZYGO 4D, autocollimators, CMMs), process and operations for manufacturability, efficiency, yield, defect performance, surface analysis (flatness, surface finish, angularity). Field Quality Project Manager / Quality Process Engineer, Stratosphere Quality Inc., Livermore, CA (Oct 2020 – Oct 2023)

Drove implementation of 3rd-party quality inspection, analysis, and resolution projects per client’s CAR for suppliers in US, Mexico, Canada, Germany, Japan, China, Vietnam, Korea and beyond. Led multiple teams of QIs at Tesla Motor, CEVA, ElectraMeccanica, Chrysler, Mack Trucks, Honda, GM, Westinghouse, and SAS Automotive in concert with quality planning by OPMs i.e. Aptive Services, Toledo T&D, FPT Zhuhai, Challenge Mfg., Mata Automotive, Henniges Taicang, Plastic TSA.

Drove components/subassembly-level DVP&R with OPM quality teams from prototype to Production. Drove design deviation resolution to meet KPIs in NCM / LT. Developed test plan, defect data acquisition, monitoring, and execution.

Managed product QI/QA/QR projects for major OPMs including AITS, Stellantis JNAP, Hydro Extrusion, Hella Auto. Improved start-up EV manufacturer QAN process. Supported quality data analysis DMS and performed RDA and PFMEA aligned w/client’s statistical solutions. Supported OPM PPAP program to meet EV maker’s QP. Conducted OJT QI operators, OJT resulting in SOP-related FR reduction and performance efficacy. Owned SCAR, MRB and RMA operations/activities for suppliers on the client site for NC parts, components, and modules.

Manufacturing Consultant (via BioDyn), Drink Inc., Richmond, CA (Apr 2019 – Apr 2022)

Principal plant installation engineering, production enablement consultant and interim program director – Managed POR selection process and contractors’ performance evaluation ensuring capital equipment BOM, shipping, installation, validation, and qualification of capital equipment. Realized significant cost savings of +54% and an average ~70% of estimated time budget.

Employed efficient preliminary equipment and process IQ/OQ/PQ validation procedures. Undertook periodic enablement program revision, readiness reviews, build plan audit, PL capability analysis, systems integration, scope expansion, and gap closure solutions implementation. Engaged in the oversight of corporal/IP assets control, document control, utilities / facility / equipment DV, ERP system evaluation, production process quality assessment, line commissioning, and operationalization.

Organized initial logistics WBS. Production line assessments include mechanical and electrical, process, modules, instrumentation, and controls integration / validation activities. Evaluate designs for integrated BTO modules, line automation, steps sequencing, PMs/repairs, HMI, machine coding, tooling, control systems, simulations, and process/technology transfer. Delivered tactical planning for international procurement. Performed risk calculations and provided mitigation proposals.

Managed supplier qualification, procurement contingency, FAT/SAT plans. Assessed facility, regulatory procedures and permitting readiness, production line build, construction/engineering change cost requirements and negotiation. Established resource allocation and provided project matrix for mechanical, hydraulic, thermal, electric, pneumatic, and chemical safety compliance.

Saved an additional +20% in systems cost by providing engineering solutions i.e., discharge production waste heat management. Implemented CPG business strategy. Incorporated optimized cost model via phased product SKU rationalization and reduced NPI formulation cost by +60% by leveraging third-party product developers and copackers. Spearheaded ERP system feature selection and implementation. Drove cost negotiation for company-wide NetSuite system customization and +87%saving. R&D, Yield and Reliability Consultant, Kohana Coffee Co., Richmond, CA (Mar 2018 – Apr 2019)

Optimized for RTD Line including Filler/Mix-Tank CIP set up and process bottleneck elimination. Designed, validated and implemented an integrated auxiliary filler filter process. Developed seamer CIP process resulting in module availability improvement achieving weekly equipment green status benchmark above 95%. Implemented formulation kitting methodology, improving RTD process time by +15% as well as eliminating ingredient contamination concerns by allocating a dedicated and controlled warehouse area.

Detail analysis of Retort capacity enhancement utilizing by modeling the equipment, process calculations and solving the process function for higher throughput with 98% accuracy, paving the way for capacity increase (40%) process approvals by Kohana Co and JBTn Corp. Performed studies to reduce/eliminate chemistry and frequency of the CIP by 80%.

Enabling QC lab with establishing test procedures. Designing test fixtures and IL inspection equipment as indicated by QA and GMP. To drive the cost down owned documentation and implementation of equipment/process modification as the ECC owner.

Eliminating high risk pre-heat process from technical analysis, feasibility studies, and concept pilot test, to process change implementation. This mitigated safety concerns considerably, by removing high-risk dairy preheat process in RTD production line. Platform Manager / Business Development, ATA Biotechnology Inc., (a BioDyn joint venture), Toronto, ON (Oct 2009 – Apr 2018)

Led technology transfer projects in both equipment and process spaces, high-capacity production systems, in order to acquire best-in- class production technology. Managed complex vendor selection activities. Collaborated with Swiss and Italian R&D labs on new product development. Delivered preliminary analysis for a variety of proprietary infused-flavor formulations.

Constructed strategic distribution contract frameworks for niche US/EU products securing 16 contracts with pharmaceutical API manufacturers and medical devices/equipment OPMs, totaling at +$25M. Prepared executive summary, preliminary feasibility analysis, ****.*******@*****.*** Union City, CA 94587 USA 415-***-**** Omid Tehrani

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business plans, sales channels, regulatory V&C, C/SKD manufacturing JV MOUs, LC/TT collaterals, in NAFTA/EAME/APAC econo-regions.

Managed SLA with IP-holders and BTO manufacturers for interventional and orthopedic, respiratory ventilators, and ambient air monitoring equipment under-licensed production. Direct-lined to executive staff at startup, engaged projects for short-circuiting operations inefficiencies at critical junctures, i.e., clinical, regulatory, product lunch transition, end-to-end throughout PLC.

Strategically aligned cross-functional groups into business focal, brought competing priorities to a budgetary path, arriving at a cost saving

+%25 through major revamping of project layout by eliminating redundancies and implementing lean manufacturing criteria successfully.

Managed PL tooling-up projects including CapEx planning and investments, coordinated EC to resolve market price pressure, provided and implemented engineering modification to production process, reducing lead-time and packaging cost at OPM. Analyzed price-point setting and with suppliers lead kitting and private label project initiatives, reducing cost and initial inventory volume by $1.5M.

Facilitated project teams, providing CSC updates and parametric/yield/project data analysis, in daily, weekly and project-based intervals, providing a clear and sustained project direction, eliminating parallel project control processes saving +%15 in operations headcount requirement.

Process Manufacturing Engineer / Product Development Engineer, NanoGreen Technology Inc., Los Altos, CA (Apr 2009 – Oct 2014)

Articulated proof of concept to Intel Corp. integration of a novel critical clean process reducing CoO +%25. Implemented iMACS® DOE, performed risk-cost analysis, formulated etch vs clean process analysis demonstrating superior surface roughness control.

Generated +$4M investment in NGT offer by Intel Capital. As an engineering liaison, laid out integration plans for potential clients, managed process/cost gap analysis, developed equipment modification, constraints analysis for OPM BOM. Advised design team in attaining minimum process variation by eliminating tolerance stacking and increasing MTTF by implementing redundancy BKM. Process R&D Engineer / Systems Integration / Senior Manufacturing Engineer, Intel Corp., Santa, Clara, CA (Jun 1996 – Jun 2009)

Thin Films department – CMP module – process development and transfer - lead CuCMP process/equipment transfer activities, group core competency development and certification program, broad defects/parametric process control, qualification, IL/EOL/eTest/Sort parametric/nonlinear dynamics analysis, and metrology optimization.

Owned Chemical Mechanical Planarization process transfer to HVM sites worldwide. Drove ultra-lean metrology, process qualification, module certification at a record +%30 gain in production ramp, an Intel global best-in-class. Ran n+1 node integrated defect reduction taskforce for VD/ECD/CMP/Lithography modules, including large Cu interconnect DR optimization, recovering +%16 Cpk, surpassing HVM yield for legacy processes.

Transformed the entire POR CMP process into a dynamic cycle, an inventively low-cost and highly successful solution, significantly limiting within-wafer and wafer-to-wafer non-uniformity exceeding the industry best-in-class RISO.

IMR department - Integration engineer - championed critical capacity/cost projects for cycle time/ equipment/ consumables improving CoP bottom-line exceeding BU quarterly goals consistently. Drove validation, qualification, and implementation of pivotal Intel factory cost initiatives as a Manufacturing and Engineering Change Control Board SPOC member recovering +$25M/Quarter. Drove in-house parts repair, inspection, functional test and qualification, and process improvement projects across fab modules including CMP, Implant, and Diffusion resulting in reduction of equipment and product failures. Organized, systemized and provided a IMR wide dashboard to increase the department output while reducing the overhead. Partnered with 3rd party service providers in eliminating cost overruns by performing on-site IQ/OQ/PQ and harmonized the incoming quality data with Intel’s QAN, procedures and policies.

Diffusion department - Atomic Ion Implant Module Engineer - lead technology transfer at R&D sites, owned process development, transfer, and sustaining activities for flash / chipset product. Drove accelerated module qualification projects for AMAT xR80, Varian E500 EHP / 1000 HC Implanter, achieving G2G reduction target. Worked with OEMs to optimize PMs procedures/cost, streamline inventory for implanter subsystems and parts, i.e. source, extraction, reducer, analyzer, mirror, faraday, scanner, neutral dump, post-scan/target chamber, dipole lens, set-up/traveling/traveling/focus faraday. Managed CoO optimization program for F11 and throughout Intel FSM VF for AMAT xR80/Varian E1000HC / E500MC EHP implanter toolsets, and alternate-sourced consumables/spares qualifications.

Intel Platform Development Group - Systems Integration / Manufacturing engineering technician- performed system level characterization, including performance modeling and thermal/EMI/acoustic emission evaluation, qualification, and CQC. Drove validation simulation, rapid prototyping, and NPI / pilot programs. Managed collaterals for quality system resource allocations. As a QAN super-user supported multiple OEM’s and internal MRB dispositions. NPI team lead for desktop, workstation and server platforms, executed systematic operations evaluation and improvement for product assembly station. Organized revision/implementation of MQR methods/ systems improvement, authored NPI Line OJT Guideline.

Skills

Process Control: JMP, R, 7-steps of problem solving, SPC, 6-Sigma, MATLAB, Mathematica, WE process control rules.

Yield/Reliability: QR/QC QAN, eTest, SORT/RISO Data Mining and Analytics, SQC Practices. LabView.

Systems Integration: EMI / Thermal / Acoustic evaluation, validation, and qualification.

CMP Equipment: AMAT Mirra Mesa, Westech, IPEC W

Clean Process: Lam OnTrak DSS200 Integra / Synergy Post CMP Cleaner ****.*******@*****.*** Union City, CA 94587 USA 415-***-**** Omid Tehrani

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Ion Implanter: AMAT XR80 High Current, VARIAN Extrion 1000 High Energy / EHP 500

iMACS Eqp: NGT CCS-1000 Critical Cleaning System (iMACS Generator)

Surface Analytics: CETR ExS Ex-Situ Tribometer, VEECO NT3300 Optical Profiler, Stylus Profilometry

Thin Film Metrology/FA: SEM, KLA Archer 500LCM / Spectra Film LD10, CD SEMs, Tescan EDx SEM, Laser Microscopy, LPC Rion, SP1 Surf- Scan, Opti-Probe, Opti-Stations, R/S film thickness, KLA-Tencor UV 1280 / ASET, NovaScan

Troubleshooting: DOE, Weibull design, Failure Analysis, Quantitative Risk Analysis, ANoVA.

Automotive: Takt Time Analysis, QPR, QPA, QI Operations Balancing vs. Factory Consumption Demand

Renewable Energy: Product Quality Inspection, QI process Development, QP Analysis

Medical Devices: Private Label Cardio/Endovascular Interventional devices.

Medical Equipment: respiratory equipment, dental orthodontics polymeric materials

Manufacturing: GR&R, GD&T, DFA/DFM, Capacity modeling/optimization, CAD/SolidWorks, PLC Integration, MES/MIS, SM/IAI, Pneumatic/hydraulic systems.

Tooling up labs / Production lines: SKD/CKD under license assembly, Raw material / Parts procurement

Validation: IQ/OQ/PQ, DVP&R, PVP&R

Pharmaceutical: Cardiovascular/Antibiotics/Oncology API

Nutrition: F&B production line setup and operationalization, RTD, Co-Packing,

Regulatory: CE Technical File/Dossier/CER/(AIMDD) 90/385/EEC Class-III, ISO14971, ISO13485, ISO9001, ISO/TS 16949, DoC, 21 CFR 807/PMA/501K, QSR

Quality System: SQF, HACCP, xGMP

Project Management: PMP (PMI PMBOK)

Enterprise Systems: NetSuite, QuickBooks

Business applications: Expert Microsoft Office/VISIO/Excel/Project/Access, ERP/SAP

Safety/Emergency Training: HSE/ERT Trainer, CPR Certified, DAN Qualified Diver

Cost Management: Budgeting, Cost Control, Life Cycle Costing, Value Engineering

Supply Chain: Planning, Sourcing, Manufacturing, Logistics, and Returns

Contract Management: T&C Audit, Negotiation, Influencing/Persuasion, RA, FA, Conflict Resolution, SM/RM

Program Lead: Communication, Dynamic Leadership, Critical Thinking, Decision-Making, Risk Management. Core Competencies Include

Platform technology development / integration / management

Quality systems development / regulatory qualification management

Production evaluation, manufacturing validation / qualification

In-depth knowledge of CMP for wafer fabs, AII and Ultraclean processes

Product cycle concept, planning, NPI / HVM implementation

Memory chipset process / yield development for backend metallization process

Lean Kanban, Kata, Kaizen, Negotiate to Yes

Whitepapers and Patents

Analytical (profile matching) process yield improvement of CMP WID/WIW Non uniformity, 2005, Intel.

Automation enhancement by close-loop dynamic process control algorithm implementation, 2006, Intel.

Implementation of iMacs Ultra Clean process in Lithography Mask operation, 2008 Intel Corp.

Impact modeling/analysis of in-situ pad performance control by applied tribology in Cu-CMP process.

US Patent (US7222403)

Education

BS, Physics (Tehran University, Physics Department)

Communication Certification Course (California State University East Bay)

Project Management Professional Certificate (Project Management Institute)

JBT Retort Operator License (CDPH )

Hazard Analysis Critical Control Point Certificate (SCS Global Services)

Safe Quality Food Audit Certificate (SCS Global Services)

GMP Better Process Certificate (SCS Global Services)

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