NPI and PMO Program Management Leader

SEEMA S. KHAN

408-***-**** NPI Program Manager Email: ***************@*****.***

15+ years’ experience providing leadership, direction and guidance in building project plans, project teams, contingencies, success metrics, and ROI for Enterprise Software and IT projects. 5+ years experience in NPI management managing process management, vendor management, schedule and risk management, hardware development and validation coordination, successful cross-functional collaboration, and execution throughout the NPI lifecycles.

PMO CONTRACT NEGOTIATION VENDOR QUALIFICATION NPI CHANGE ORDERS BOMS PROCESS IMPROVEMENT AGILE SCRUM QUALITY SUPPLY CHAIN

PROFESSIONAL SUMMARY

PMO MANAGEMENT:

●Implementing PMO processes based on the PMBOK-6/7 knowledge base. Standardizing Project Charter, SOW, RACI Charts, means of communications. Schedules, Meeting Minutes, Resources (FTE).

●Leading and managing large, cross-functional initiatives that drive the strategic goals of the business stakeholders from inception to close.

●Leading and managing large, cross-functional initiatives that drive the strategic goals of the business stakeholders from inception to close. Reducing costs by managing FTEs tightly and increasing revenue by carefully evaluating revenue associated with different products is the key initiative performed.

●Clearly defining Work Breakdown Structure and mapping it to Work Schedule, and task dependency.

●Manage contract negotiation and supporting administrative tasks including MNDAs, and writing SOWs and POs by collaborating with legal, contracts teams, product management and R&D.

●Establishing subject matter expert in developing strategies for complex negotiations and able to coach others in the team for those techniques

●Renewing contracts with all the existing OEM partners 500+ Millions of revenue generating contracts.

●Leading portfolio of 20+ projects on budget, and within schedule.

●Leading programs and projects from the concept phase through launch, in the Agile Scrum environment.

●Proactively managing risks and anticipating potential issues which pose a threat to achieving project goals.

ENTERPRISE NETWORK:

●Manage and execute system level testing, interoperability testing, performance testing and Beta testing for enterprise powerhubs, Routers, ATM switches

●Manage and lead Metro Optical 1-10 gig switches (central switch) LMS 1000, LMS 2500 (Edge switch) product line from concept to launch that brought the revenue of $60 Million per quarter.

NPI MANAGEMENT:

●Overall Program Management: Execution throughout the NPI lifecycle using excel and SAP.

●Operational creation of project plan incorporating cross-functional collaboration of project requirements.

●Program execution with daily tracking, milestone, and deliverable management.

●Proactive risk management through continuous schedule and mitigation management

●Weekly status reporting, monthly executive program reviews.

●Management & documentation of program impacts in real time; evaluation and implementation of process improvement.

●Implementation of NPI qualifying process standardization.

●Perform post-production/sustaining program activities as assigned/required.

STAKEHOLDER MANAGEMENT:

●Define Stakeholder RACI chart to clearly define stakeholder responsibility and influence level.

●Establish a standard means of communication for cross functional teams and executive management.

●Develop a Business Case for every project to evaluate ROI, profitability, and cash flow.

●Meet executive management and give status presentations and make sure project delivery is aligned with the strategic initiative of Quarter revenue.

ML/AI AND COGNITIVE PROJECT MANAGEMENT:

●Define SOW by translating business requirements and customer problems into ML/AI requirements by collaborating with stakeholders and understanding their needs.

●Manage implementation of American Airlines reservation features into IBM Watson App (AI configures chatbot)

●Planning and project execution using agile methodologies.

PURCHASING AND REQUISITION:

●Work with multiple OEM simulataneously to accurately set up BOM, FAI planning and execution.

●Create Purchase Orders / Requisitions, maintain invoice tracking and Goods Receipts.

●Place order, track and actualize material to support development builds & product ramp.

●Drive material delivery through Procurement and direct with suppliers to ensure on-time delivery.

●manage the BOM cost integrity, risk analysis, identifying risk and developing mitigation plans for all high risk components.

●Persuasive Communicator; well-developed verbal/written and presentation skills; able to communicate effectively and build rapport with clients and the customer, able to listen actively and attentively.

PROCESS IMPROVEMENTS AND IMPLEMENTATION OF SIX SIGMA:

●Lead and manage process improvement by automating and implementing six sigma and lean methodologies. This improved the delay in certain key activities and improved the performance.

●Standardize tools and processes. Implemented processes for NPI qualification that meets strategic initiative of the company. This eliminated low revenue generating projects and the resources released were reassigned to high revenue generating projects decreasing the expenses and improvising the revenue.

MEDICAL DEVICE/ DIAGNOSTICS PRODUCTS -FDA REGISTRATION

●Demonstrated experience with Project Portfolio Management methodologies

●Proven experience managing FDA registration, Device Registration, Pre-approval Market (PMA) etc.

●Proven experience in leading teams to prepare for Phase Gate and Go/No-Go decisions by executive leadership

●Demonstrated experience in managing clinical trials teams and guiding them what is needed by FDA.

●Demonstrated experience in managing and implementing compliance with FDA processes including Registering the product, getting the pre-approval Market (PMA) 510-K in compliance to 21 CFR 812

●Proven experience in managing implementing and correcting the compliance with 21 CFR 11 (Digital Document Control), Quality System 21 CFR 820, and ISO 9001/ 13485

●Keeping documentation records electronically as well as hard copy folders.

TECHNICAL EXPERTISE: Phase Gate Processes / ISO 9000/Waterfall /AGILE/ Microsoft Word /Access / MS Project / MS Office 360/Embedded Software/AI/Machine Learning/SharePoint/SmartSheet/JIRA/Six Sigma

EDUCATION:

Six Sigma Certification, ThermoFisher University 2022

Best Manufacturing Practices, ThermoFisher University 2021

Agile Scrum Certification, San Jose State University 2018

PMP Certification, San Jose State University 2016

MS – Computer Science, University of Oklahoma 1990

B.S. Chemical Engineering, Z. H. College of Egg, AMU India 1986

CAREER ACCOMPLISHMENTS

EXPERT CONTRIBUTOR, DATA ANNOTATOR PM, SNORKEL.AI 04/2025-PRESENT

Working as an expert contributor to curate data to train, tune, and/or evaluate AI models . This includes tasks like identifying objects in images, tagging pieces of text, or generating multiple-choice questions to support AI models that depend on high-quality labeled data for accuracy. subtopics within Management Science & Engineering that I am working on Decision Analysis, Financial Engineering, Innovation Management, Project Management and Risk Management.

PROGRAM MANAGER (PMO), THERMO FISHER SCIENTIFIC 09/2021-12/2024

Lead and manage large, cross-functional initiatives that drive the strategic goals of Thermo Fisher diagnostics business stakeholders from inception to close. Align all the OEM programs with the company strategic goals with measurable KPIs.

●Acted as the NPI program manager and played a pivotal role in facilitating actions and driving excellence in program/project management.

●Owned the day-to-day coordination of activities at the diagnostic division, including new product introduction (NPI) builds, design of experiments, testing, failure analysis, material deliveries, and facility work.

●Maintained an integrated master schedule with clear owners, priorities, dependencies, and due dates.

●Established a weekly communication Tier Board Meeting that summarized upcoming activities, critical path activities resolution, required onsite support, progress, risks, and decisions.

●Managed cross-functional teams to work on assigned activities in SmartSheet and deliver within assigned deadlines.

●Supported build readiness by coordinating materials, equipment, documentation, staffing, and other requirements.

●Ensured results from experiments, testing, and failure analysis are documented and shared with the appropriate engineering teams.

●Coordinated site infrastructure and workspace needs in partnership with Engineering, Operations, and IT.

●Established supplier selection criteria, evaluated suppliers, managed the supplier selection process, and the final supplier selection in partnership with hardware engineering, manufacturing design engineering, and supplier quality team.

●Negotiated master agreements and SOW with suppliers to establish best-in-class pricing, flexibility, quality, delivery, payment, warranty and service terms.

●Drafted, reviewed and negotiated a wide range of agreements (NDAs, MSAs, SaaS agreements), order forms, SOWs and amendments required to support business activities.

●Managed design and cost trade-off conversation during development stages to influence production design and manufacturing processes for the best decision of the product.

●Managed communication of a weekly production schedule using capacity, material constraints, and demand as inputs.

●Managed assigned NPI/Sustaining projects at both strategic and tactical level. Monitor production progress and adjusted schedules as needed, to meet changing demands.

●Managed shipment schedule to meet customer delivery commitments.

●Provided guidance on production capacity, lead times, and volumes to support Sales and Operations. Identified potential capacity bottlenecks that will affect the build plan.

●Managed work orders generated from the MRP run and ensure they seamlessly get created and communicated to relevant team members.

●Managed communication with cross functional teams to manage supply and demand issues, resolved work order variances and tracked root cause analysis on production failures.

●Determined and managed potential line shortages by analyzing build schedules, shortage reports, on hand inventory reports and supplier delivery information.

●Managed Overall Program execution throughout the NPI lifecycle using SAP NPI process and Smartsheet program management tool .

●Managed the operational planning using Word, created a project plan incorporating cross-functional collaboration of project requirements, schedule, milestones, internal/external dependencies, risk, target release and approvals for project execution commitment.

●Managed Program execution with daily tracking, milestone, and deliverable management, which includes validations, material readiness, Arena bill of materials (BOM) change order reviews and approvals, BOM lock & gate reviews for phase advancement.

●Proactively managed risk through continuous schedule and mitigation management, assuring deliverables and technical commits are met on time.

●Managed the BOM cost integrity, risk analysis, identifying risk and developing mitigation plans for all high risk components.

●Managed hardware bills of material (BOM) management and Engineering Order Changes (ECOs)

●Management & documentation of program impacts in real time; evaluation and implementation of process improvement.

Continuous Improvement and Strategic Alignment:

●Conducted thorough gap analysis within the company from the perspective of reducing overhead.

●Led total cost reduction program to achieve the lowest possible total cost which covers product cost, transportation cost, inventory cost and cost of quality

●Implemented process and tools to minimize overhead and maximized implementations on high revenue generating projects.

●Evaluated current process and recommended continuous improvement to evolve process Execute ECO implementation requirements.

●Implemented NPI Qualification Process in compliance with Strategic Initiatives of the company where every new project has to go through a qualification process and resources are assigned to those projects that pass the process. This process eliminated the low revenue high cost projects & gave a R&D focus on high revenue generating projects.

●Improvised the purchasing by implementing Six Sigma principles of accurate forecasting and minimal waste and overhead. Managing all OEM communications including SOW, and Payments etc.

●Improvised the revenue 30% per quarter and reduced the cost by 15-20%.

NPI PROJECT MANAGER (PMO), IBM COGNITIVE CLOUD & AI 10/2019-5/2021

Worked as a NPI project manager for IBM data Center upgrades from inception to close at Silicon Valley Lab.

●Established supplier selection criteria, evaluated suppliers, managed the supplier selection process, and the final supplier selection in partnership with hardware engineering, manufacturing design engineering, and supplier quality team.

●Negotiated master agreements and SOW with suppliers to establish best-in-class pricing, flexibility, quality, delivery, payment, warranty and service terms.

●Drafted, reviewed and negotiated a wide range of agreements (NDAs, MSAs, SaaS agreements), order forms, SOWs and amendments required to support business activities.

●Developed and issued high value/risk RFPs, RFIs and RFQs. Coordinating and leading proposal reviews, evaluations and recommendations for contract awards.

●Managed design and cost trade-off conversation during development stages to influence production design and manufacturing processes for the best decision of the product

●Developed and implemented supplier performance measurement system and conducted periodic supplier business reviews with the management and cross functional team

●Influenced the direction of suppliers' business investments and roadmaps to align with clients strategic goals for mechanical technology development

●Managed timely delivery of materials, resolving issues in case delivery might be late, switching to alternate vendors or escalating with the existing vendors.

●Established and maintained collaborative relationships with teams and suppliers to reduce overall costs.

●Defining, and driving engineering KPIs, metrics, reporting dashboards to track timely delivery

●Heavily involved in New Product Introduction, market launches, infrastructure scalability / reliability, supply chain and operations for IBM Cloud Platform.

Continuous Improvement and Strategic Alignment:

●Led total cost reduction program to achieve the lowest possible total cost which covers product cost, transportation cost, inventory cost etc.

●Implemented NPI Qualification Process in compliance with Strategic Initiatives of the company where every new project has to go through a qualification process and resources are assigned to those projects that pass the process. This process eliminated the low revenue high cost projects & gave a R&D focus on high revenue generating projects.

●Improvised the purchasing by implementing Six Sigma principles of accurate forecasting and minimal waste and overhead. Managing all OEM communications including SOW, and Payments etc.

PROGRAM DIRECTOR, C2 EDUCATION 04/2017-02/2019

Managed the operation of ten centers, managed P&L for the Northern California region, and managed both regional and global HR processes including Recruiting, Onboarding. and Learning and Development

●Managed multi-million dollar initiatives that impacted multiple cross functional organizations.

●Implemented customer driven value- added services and consistently surpassed the projected revenue from month to month making NorCal C2 centers highest revenue generating territory.

●Re-engineered the operation to handle 20-30% growth per month among 15 centers operating in Northern California. Many Centers produced $100,000+ of revenue per month exceeding the target revenue by 50%.

Continuous Process Improvement:

●Conducted thorough gap analysis within the company from the perspective of reducing overhead.

●Implemented customer driven value-added services and consistently surpassed the projected revenue from month to month making NorCal C2 centers highest revenue generating territory.

●Closed low performing centers and open new centers in high traffic visible locations.

●Promoted our services through Groupons, Living Socials, Nextdoor and other Ethnic groups to bring visibility of our products, and services thus increasing the enrollments by 20% per quarter.

●Created partnership programs with charter schools and public schools where College counselling programs were not established that added a huge consistent revenue.

●Re-engineered the operation to handle 20-30% growth per month among 15 centers operating in Northern California. Many Centers produced $100,000+ of revenue per month exceeding the target revenue by 50%.

PROJECT MANAGER, SWING EDUCATION 12/2015- 3/2017

Swing Education provided a mobile app solution for the schools and community colleges to recruit Adhoc faculty in a real time.

●Prepared SOW, work breakdown, schedules and sprint planning in an agile environment for the program team and managed day-to-day progress through JIRA for HR App design & integration to ERP.

●Managed and executed SOW, Resources Planning, Budget, & Delivery time etc. using JIRA

●Managed the SaaS development operation from conception to launch and deployment.

●Led functional teams like (technical product, technical program, and software engineering).

●Supported service deployment in 10 different schools and 5 community colleges. Implemented value-add Customer On-boarding training to educate customers about the policies and checklists of how to manage the temporary staff and support them by providing relevant information. On-boarding training succeeded in 100%

Continuous Process Improvement:

●Conducted gap analysis within the company from the perspective of the number of complaints we received regarding bad quality of substitute teachers provided. Many schools dropped partnerships.

●Standardized value-add On-boarding training to educate substitute teachers about the policies and checklists of how to manage the classes and provide them with proper information so they can be well prepared to teach.

●Stabilized and scaled the partnerships with 18+ charter schools and public schools to provide exceptional temporary substitute teachers who were knowledgeable, and well trained.retention of existing partner schools and community colleges.

NPI PROJECT MANAGER, SJSU INNOVATION LAB (MEDICAL DEVICE ) 10/2012-08/2015

Acted as a junior project manager overseeing NPI project “UControl” tactical level production progress and adjustments in schedules as needed to meet changing demands.

●Created, maintained and communicated a weekly production schedule using capacity, material constraints, and demand as inputs.

●Managed “Ucontrol” project both strategically and tactically to monitor production progress.

●Managed shipment schedule to meet customer delivery commitments.

●Provided guidance on production capacity, lead times, and volumes to support Sales and Operations. Identified potential capacity bottlenecks that will affect the build plan.

●Managed work orders generated from the MRP run and ensure they seamlessly get created and communicated to relevant team members.

●Managed communication with cross functional teams to manage supply and demand issues, resolved work order variances and tracked root cause analysis.

●Evaluated current process and recommended continuous improvement to systemized ECO implementation requirements.

●Determined and managed potential line shortages by analyzing build schedules, shortage reports, on hand inventory reports and supplier delivery information.

●Escalated Potential issues or target misses where necessary to management Perform other tasks as assigned

●Achieved FDA requirements pertaining to 21 CFR 11 compliance for U-Control product line. Closely track Verification and Validation protocols and reports for Regulatory submissions.

●Provided complete leadership in resolving action items, and utilizing the resources fully. Ensured adherence to established project management methodologies and best practices.

●Managed the development of project timelines and managed any changes, such as future timeline changes that may result from changes in scope, delays in schedule or lack of resources.

●Defined Quality Systems or Design Controls for Universal Remote Control with medical assistance features.

●Fully supporting CAPA (Corrective Action Preventive Action) by providing the compliance of FDA 21 CFR 820.100.

●Assessed project performance and implemented changes as necessary to ensure project quality success matrix and quality objectives are within specified baseline.

●Coordinated all project update meetings and presented the presentation for project status reviews to internal and external stakeholders.

Continuous Process Improvement:

●Implemented and standardized the PMO processes and tools.

●Got early feedback from seniors regarding the product usability, ease and need of additional features.

●Implemented electronic document control system for relevant documents.

VIRTUAL COMMUNITY PROGRAM MANAGER, GRADE POTENTIAL 07/2010- 06/2012

●Managed the community operation along with connectivity issues, login failures and network conflict problems. Gather student learning outcomes virtually and provide the feedback to the Engineering team. Created and managed revenue of $30 M+ for the west coast accounts.

●Managed the West Coast operation for hiring STEM professionals and assigning them to the appropriate accounts.

●Managed community operations along with connectivity issues, login failures and network conflict problems.

●Coordinated students' learning outcomes virtually and provided feedback to the Engineering team.Managed a revenue of $10 M+ for the west coast accounts.

PROGRAM MANAGER, WORLD FINANCIAL GROUP 08/2004-06/2010

●Coordinated students' learning outcomes virtually and provided feedback to the Engineering team.Managed a revenue of $10 M+ for the west coast accounts.

●Worked with 1-2 Million dollar budget to provide network infrastructure in the company and automation of the Insurance Claims filing, data analysis, enrollment of new clients, management of existing clients like sending reminders to expiring accounts and automatic renewal of the policy upon approval and so on.

●Worked with different health insurances like Medical, Medicaid, short term and long- term disability etc. to support the development of Claims Automation and Tools in Agile Scrum methodology.

●Delivered performance metrics and analytics to the brokers and financial analysts. Saved WFG a lot of money and time by automating alerts to expired accounts and creating renewals online.

●Increased P&L by 35% of the projected revenue on a quarterly basis.

SENIOR PRODUCT MANAGER, LUMINOUS NETWORK 6/2000 – 7/2004

Led marketing requirements for Metro Optical 1-10 gig switches (central switch) LMS 1000, LMS 2500 (Edge switch) product line that brought the revenue of $60 Million per quarter.

●Defined marketing requirement document for 1-10 gigabit metro-optical switch LMS2500 (Edge Aggregation switch). Managed the entire program from conception to launch for LMS1000.

●Managed and maintained the relationship with business and technology stakeholders including Architects and potential customers on the regular basis understanding their needs and bottleneck in their network.

●Managed scope, milestones, schedule and budget across the program to ensure completion of goals.

●Led cross-functional product development teams from product definition to release and eventually to production for Metro Ethernet switching products.

●Managed the forecast (Bills of Materials)BOM and managed the procurement of all the boards, chassis, cable, test analyzers, and other off the shelf materials with a purchase order(PO).

●Wrote RFPS (Request for Proposals for various customers like SIGMA NETWORKS, Level 3 and IP NETWORKS.

●Led Beta programs with multiple customers and managed the customer demands and effectively delivered product releases to meet their needs.

GROUP LEAD, NETWORK TEST, FORE SYSTEMS (MARCONIE SYSTEMS) 8/1996 –5/2000

Managed the systems engineering program as a single point of contact. Managed Ethernet Routers, a product line that brought revenue of $250 million per year. Improved the stability and performance of existing line of products and newly integrated lines of product hence increased the sale from $100 million to $250 million per quarter.

●Managed the ATM backbone, Ethernet in the edge tests setups, limitations of design and overall network throughput and health for major federal clients.

●Managed the budget, people and equipment resources for the Ethernet division of Fore Systems.

●Led the white box testing of various supported LAN protocols like IP, Bridging & Spanning Tree, OSPF, RIP V1, and RIPV2, BGP4, IPX (802.2, 802.3, SNAP) APPLETALK, VRRP, ATM, MPOA, LANE, 1483-PVC, CLIP PVC, FIP etc over different hardware media like FETH, FDDI, and ATM

●Managed the Performance Testing, Interoperability Testing ( with Cisco routers), System level testing of enterprise routers software and firmware releases in critical federal accounts and provided the infrastructure for bug fixes & patch releases in the field.

●Managed the release dates of various releases and resolved any critical outstanding issues relating to releases, resources, features, or release dates.

●Conducted full First Article Inspection for final releases.

STAFF TEST ENGINEER, NETWORK GENERAL 6/1993- 7/1996

Managed the system level testing, protocol testing, functionality testing for Sniffer line of products in Client Server environment. Network General Sniffer is a tool that is widely used in detecting any failures in enterprise networks. Sniffer tool decodes all 7 layers of OSI model and gives details where the failure may be and is a great tool for network troubleshooters.

Contact this candidate