Engineering Manager Hardware

SEEMA S. KHAN

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

With over 18+ years of experience in a program management office (PMO) providing leadership, direction and guidance in building project plans, project teams, contingencies, success metrics, and ROI within IT and operations. I have led diverse teams to drive innovation, process improvement, strategic alignment of project portfolio with executive initiatives, and improvisation in P&L. 7+ years of experience working in Medical Device products (Class I, II, III) specializing in Medical Diagnostics IVD products and 2-3 years of experience with the development of IVD products.

PMO Management Agile Scrum Phase Gate SDLC FDA Compliance Governance Framework

ACHIEVEMENT SUMMARY:

IMPLEMENTATION OF PMO PROCESSES AND GOVERNANCE FRAMEWORK:

●Implement PMO processes based on the PMBOK-6/7 knowledge base. Standardized PDLC processes to be followed company wide. Developed procedures and templates for Project Charter or SOW, Project Plan, Project Teams, Work Breakdown Structure, Resources (FTE), Project budget,RACI Charts, means of communications, Project Schedules, Meeting Minutes for Software, hardware,Medical Diagnostics and Education Sectors.

●Drive the creation and chartering of cross-functional task forces to address emerging issues (e.g., global-local content creation, medical-legal compliance).

●Ensured the department’s portfolio of client projects is properly assigned to the governance analysts and that the governance analysts are properly preparing the gate review materials in advance of IT Integrated Governance meetings.

●Standardized on PMO tools (Smartsheet, and 10,000 ft) to be used for project execution and status tracking.

●Defined the governance framework and implemented with the support of senior executives.

●Worked with IT and enterprise leadership to establish key performance metrics for IT; works with IT line functions to develop departmental metrics.

●Defined measurable KPIs for various cross functional groups aligned with strategic initiatives of the company

●Hired, trained, mentored and built a progressive PMO team.

●Developed PMO training for processes and procedures across various cross-functional groups for clarity.

●Implemented procedures and processes for phase gate specially for Medical Device Companies.

●Implemented six sigma lean techniques to eliminate waste, and redundancies within operations

COMPANION/IN VITRO DIAGNOSTICS PRODUCTS -FDA COMPLIANCE

●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.

CLINICAL STUDIES FOR IVDR COMPLIANCE

●Supported IVDR compliance activities including the creation of technical files, post-market surveillance activities, and new product development documentation.

●Managed various clinical studies like CPR, APR, PEP, PER, PMS, SVLRR, and SSP for FDA and EU regulatory submissions.

ELECTRONIC DOCUMENT CONTROL MANAGEMENT (MEDICAL DEVICES) (ISO13485/FDA 21 CFR PART820)

●Implementing Electronic documents control over Oracle System to maintain all documents

●Managing and keeping track of all the latest version documents for TDM products.

●Ensuring all the latest version documents are loaded and maintained in the electronic database and physical folder for easy accessibility.

RISK MANAGEMENT AND CONTROL FOR MEDICAL DEVICES (ISO14971)

●Define Risk Management plan, outlining Intended Use, defining products’ risk acceptability etc.

●Perform Risk Analysis and identify all the hazardous situations and foreseeable sequence of events.

●Build a Risk Acceptability Matrix along with severity and probability of occurrence.

●Control the Risks by mitigating or escalating it. Enforce protective measures in the manufacturing process.

CUSTOMER AND 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.

●Manage and accountable for defining, directing, monitoring, all service delivery activity and support functions for the OEM partners like Abbott, Roche, Ortho and Beckman.

●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.

AGILE SCRUM METHODOLOGY:

●Implement Agile Scrum implementation, building team, defining processes and training team as Scrum Master, Product Owner, Stakeholder and Project Manager.

●Help team define SPRINTS, and Backlog grooming. Managing programs through JIRA software.

BUSINESS ENGAGEMENT & TRANSFORMATION:

●Manage and successfully influence cross-functional team members to achieve project goals.

●Support team members and establish healthy, collaborative relationships with cross functional teams..

●Evaluate portfolio of projects against business strategic initiative for long term relationship, and revenue perspective.

●Revise and eliminate projects that are not aligned with the business unit revenue stream and add on the new revenue generating projects.

CHANGE MANAGEMENT :

●Manage and implement Six Sigma principle in the manufacturing department, and Lean concepts through R&D, QA, Product Management and Operation.

●Assisted executive management in devising organizational change framework as well as Process change framework with the measurable KPIs.

NPI PROGRAM MANAGEMENT:

●Define NPI requirements and manage the entire life cycle from ideation to launch by coordinating the work with cross Functional teams

●Standardize the NPI process aligned with the strategic initiative of the division.

QUALITY ASSURANCE AND LEAN MANAGEMENT

●Establish and maintain quality standards and processes to ensure that healthcare projects meet regulatory requirements and industry best practice

●Providing continuous improvement by implementing lean six sigma methodologies in daily operations.

TECHNICAL EXPERTISE: Phase Gate Processes / ISO 9000/JIRA /AGILE/Embedded Software/ Microsoft Word /Access / MS Project /Dropbox/MS OFFICE 360/ Excel/SharePoint/SmartSheet/10,000ft/JIRA/ Six Sigma/SDLC/SAP

EDUCATION:

Six Sigma Certification, ThermoFisher University 2022

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

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

Led and managed large, cross-functional initiatives that drive the strategic goals of Thermo Fisher IN VITRO diagnostics business stakeholders from inception to close. Managed a project portfolio of 20 IVDR TDM projects. Aligned all the OEM programs with the company strategic goals with measurable KPIs.Developed and directed detailed work plans, schedules, project estimates, spending, resource plans, and status reports. Conducts project meetings and is responsible for the definition and implementation of project risk mitigating measures. Reported project goals (e.g., KPI) to enable teams and functions to measure and improve quality, efficiency and effectiveness. Implemented Electronic document control for maintaining all documents and records electronically.

Clinical QC Software products:

●Managed and supported the research team for QC Lablink software platform in execution and analysis of clinical data, feature support, AI & machine learning capabilities, etc.

●Wrote the SOW and functional requirement documents along with a detailed project plan with the required resources, budgets and timelines.

●Transformed Waterfall team into hybrid Agile Scrum implementation team and led the Agile Practice, putting in place the systems, processes and knowledge of Agile Scrum to develop Lablink software into SPRINTS.

●Managed the compliance of Medical Device SDLC phase gate review at every phase starting from Concept phase, Feasibility phase, planning phase, design Control, Verification and Validation, Launch, Post Market Surveillance.

●Managed planning and execution of Clinical QC platform programs in support of the continuing evolution of the organization's software products.

●Partnered with cross-functional software development teams to help them prioritize, plan, track and execute complex, cross organizational programs.

●Performed program analysis, manages risk, identifies and influences necessary course corrections, and communicates program status and activities across multiple levels of management.

●Managed risks and resolved issues that affect release, scope, schedule, and quality of highly visible, complex programs.

●Implemented Electronic document control for maintaining all documents and records electronically.

●Managed LabLink QC Software development in Saas implementation in Agile Scrum Environment.

●Managed SPRINT contents, Backlog grooming, SPRINT demos and overall health of the program.

●Managed the program communication to executive management and important stakeholders.

In Vitro Diagnostic (TDM) products:

●Managed project portfolio of 20+ TDM IVD products for Abbott OEM and released 2+ essays for TDM IVD Beckman OEM, 10+ products in QC control with Ortho OEM.

●Managed IVD products from concept through development to formal release. This includes managing project schedules, identifying and mitigating risks, managing the Design History

●Managing and working alongside Quality and Regulatory to identify and evaluate hazards.

●Managing Analytical Studies, Clinical Studies, Stability Studies, Regulatory and Packaging requirements with cross-functional teams.

●Managed and accountable for defining, directing, monitoring, all service delivery activity and support functions for the OEM partners like Abbott, Roche, Ortho and Beckman.

●Ensured and implemented phase gate product life cycle, perform design control and design reviews.

●Implemented Electronic document control for maintaining all documents and records electronically.

●Worked with labeling project manager, and core teams to make sure Artwork and IFU are approved by the core team, and OEM partners and updated in a timely manner.

●Provide manufacturing engineering support for the development and manufacturing of new products

●Evaluate proposed designs for manufacturability and provide DFM recommendations

●Identify interdependencies and look for strategic ways to to mitigate risks throughout the project and guiding the team around potential obstacles.

●Managing critical path activities laid out in Smartsheet and successfully removing team’s roadblocks.

●Maintained and controlled project budgets ($1-3 millions) in collaboration with Finance and cross-functional departments. Developing Business cases for all new products and presenting to senior leadership.

●Executed resource management, identifying resource gaps, and working with management to address resource constraint issues using 10,000 ft/Smartsheet.

●Facilitated the completion of various design control documents (project plans, design inputs, design outputs, risk, etc.) and maintaining design history files to ensure adherence to quality procedures.

●Identified, documented, and mitigate project risks and contingency plans.

●Managed all OEM communications including SOW,Scope creeps and Payments etc.

●Experience with medical device development standards e.g. ISO 13485, FDA 21 CFR 820 Experience working with products incorporating hardware, firmware and software.

●Managed projects in an FDA regulated environment, submitting projects for 510 compliances & CE Mark and EU compliance.

Continuous Improvement and Change Management:

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

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

●Reduced costs by eliminating costly consultants and reshuffling FTE from low revenue projects to high revenue projects.

●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%.

SENIOR PROGRAM MANAGER, IBM COGNITIVE CLOUD & AI 10/2019-5/2021

Led and managed large, cross-functional initiatives that drive the strategic goals of Silicon Valley Lab (SVL) business stakeholders from inception to close. As a PMO Program Leader I played a vital role in driving operational efficiency, ensuring successful project implementation, and contributing to the overall advancement of the Portfolio Strategy.

●Led and managed large, cross-functional sourcing initiatives that drive the strategic goals of IBM Cloud business with cognitive and machine learning features supported through Watson App from inception to close.

●Managed transition of American Airlines operation over IBM hybrid cloud and implementation of cognitive features through Watson App.

●Translated business problems and customer requirements cumulatively into ML/AI requirements by collaborating with stakeholders and understanding their needs.

●Managed project scoping (SOW) to define project goals, deliverables, and success criteria.

●Supported the lifecycle of a large portfolio of complex programs, leading project-level planning, optimizing standards, identifying areas for improvement, delivery, and communication management.

●Managed and accountable for the successful implementation of complex and highly visible, high impact PMO initiatives that impact all IT processes.

●Managed stakeholders throughout the project lifecycle to ensure effective communication and alignment.

●Implemented all the Planning and project execution using agile methodologies

●Met with internal clients on a regular basis to understand client needs and to strengthen client relationships.

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

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

Managed the operation of ten centers, managed P&L for the Northern California region, regional HR processes, and operational excellence. Implemented PMO processes, standardized processes and tools to manage the portfolio of projects.

●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%.

SENIOR 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. Implemented PMO processes for SaaS product development from concept to launch.

●Prepared SOW, work breakdown, FTE resources, budget, schedules, and communication means.

●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% retention of existing partner schools and community colleges.

SENIOR PROGRAM MANAGER, SJSU INNOVATION LAB (MEDICAL DEVICE) 10/2012-08/2015

As a project manager I had the opportunity of managing the project developed for disabled veterans who can manage devices inside home and their health vitals through Mobile App. I managed this product from conception to launch, along with FDA approval, market strategy, customer feedback, product branding, vendor management and timely product launch.

●Worked with the cross functional team to finalize SOW, project timelines, resources, budgets, quality and regulatory resources, and procurement needs.

●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

●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.

●Collaborated across all the functional areas (R&D, Marketing, QA, Regulatory, Clinical, operations, service, etc) necessary to successful project completion and delivery

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

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

●Implemented Electronic document control for maintaining all documents and records electronically.

●Setup Universal Control BOM structures; work with project team to make sure document owners update documentation and save to the central location

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

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

VIRTUAL COMMUNITY PROGRAM MANAGER, GRADE POTENTIAL 07/2009- 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.

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 entire program for LMS1000.

●Managing company marketing events, setting up the booths, and managing all marketing collateral.

●Managing company event registration in the domestic and international trade shows.

●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.

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