Manager Project

Robert Bertrand, PMP, CSM **** Meadow Drive. Carlsbad, CA 92010 760-***-**** *****************@*****.***

My experience includes program/project management, client management, outsource management and all aspects of a PMO implementation. I have been responsible for the successful delivery of products, software, and infrastructure projects for over fifteen years in multiple industries. I have managed client relationships and led major software and product development efforts for Fortune 500 companies in excess of $30M, including: Data Warehouse, New Product Development, Custom Software, SaaS solutions, COTS, and Infrastructure initiatives.

PROFESSIONAL EXPERIENCE

Senior Program Manager ICU Medical ( contract ) November 2020 - current

ICU Medical is a leading provider of infusion therapy systems and critical care equipment that helps clinicians get accurate real-time access to patients' hemodynamic and cardiac status with an extensive portfolio of monitoring systems and advanced sensors & catheters. I am currently on a 6-month contract assignment to manage their Design History File Re Baseline program, where my responsibilities encompass

Manage twelve product teams composed of members representing R&D- Engineering, Quality, Regulatory, Medical Affairs and Clinical representatives to remediate files for MDR submission

Key activities are creating Protocols, Test Execution and Reporting, as well as Biocompatibility tests.

Responsible for tracking of overall team progress and provide detailed management status reports and updates

Create and maintain dashboards and reports that effectively communicate progress, risk and achievements to stakeholders.

Collaborate with senior management on issues and barriers to on time completion

Managing related project to update IQ/OQ/PQ for validation of packaging equipment in Mexico and Costa Rica facilities

Manage expectations in an environment of continual change and uncertainty.

Senior Manager, Program Management ResMed Sept 2015 – November 2020

ResMed is a leading developer of medical equipment in the respiratory field and the world’s largest provider of connected healthcare solutions. Serving in several project management roles, I currently manage the PMO team within Digital Platform Engineering and Operations, in support of Digital Health Technology software products and over 2 million daily uploads. Current initiatives include the implementation of Site Reliability Engineering support model, a global cloud native platform rollout (PaaS), and the initial migration to AWS for cloud-based services. Key responsibilities in my roles include but are not limited to:

Senior Manager, Program Management: August 2018 – current

Responsible for administration of Portfolio Management Office for Digital Engineering and Operations

Manage project managers, scrum masters and system analysts in US, Canada, Australia, and France

Sponsor agile transformation project to improve and standardize agile processes for scrum teams

Refine the work intake and planning process to align with SAFe methodology and Product Owner needs

Monitor the portfolio of initiatives and performance to plan on projects and DPE services

Improve metric reporting and roadmap planning for Engineering and Operations teams

Enable visibility of status and issues to ensure informed conversations with customers on priority and risks

Responsible for developing, motivating staff members, and providing guidance

Senior Program Manager: Oct 2017 – July 2018

Program Manager: July 2016 – Sept 2017

Senior Project Manager: Sept 2015 – June 2016

Aug 2013 – Aug 2015 Johnson and Johnson Irvine, California

Sr. Project Manager (contract)

Advanced Sterilization Products, a division of Johnson and Johnson, is a Medical Device company that manufactures infection prevention solutions for hospitals and clinics. Within the Research and Development PMO, responsible for NPD program management activities, and managing deliverables of cross functional teams of scientists, mechanical, software, and electrical engineers in a QMS driven environment.

Consumables Improvement: Managed initiative to improve the quality and capacity of consumables products. ASP creates bio indicators as our consumable for sterilization devices and we could not deliver enough to meet demand. Worked with team of biologists and chemists to increase germ production in labs for the consumable bio indicators, and work with manufacturing team to increase production of units.

Project Mercury: Concept Stage thru Phase 1: “Black Box” - a new S/W and H/W solution to transfer data from medical devices via hospital networks to a web portal for BI reporting

Drive the deliverables for the Core Team from R&D, Software, Quality, Regulatory Marketing, Packaging

Develop RFPs and SOW for contracted S/W and H/W vendors

Create integrated project schedule across all work streams

Right size Phase One deliverables to align with Quality Management and Regulatory requirements

Project Darwin: Concept Stage thru Phase 3; New Endocleanse unit for High Level Disinfection

Drive the deliverables for the Core Team from R&D, Software, plus Quality, Regulatory, Manufacturing, Service, Marketing, Packaging, Finance and Industrial Design

Create and maintain the schedule in MS Project to adhere to New Product Life Cycle.

Manage manufacturing partner integration activities and production move from Malaysia to Baja MX

Manage schedule for our chemical supplier for new reagent and consumables products

Implement project controls for risk, issues, communication and schedule management

Identify and manage critical path tasks that gate Regulatory Submission goal

Coordinate simulated use tests and GUI requirements with hospital clinicians

Project Phoenix: Concept Stage thru Phase 1; New Sterrad device for surgical instruments

Drive the deliverables for the Core Team from Software, Quality, Regulatory, Manufacturing, Service, Marketing, Packaging, Finance and Industrial Design

Implement project controls for risk, issues, communication and schedule management

Create and maintain the integrated project schedule, weekly reports and governance documents

Mentor and manage 17 project leads in R&D and Lab on their deliverables; BOM, Parts, Drawings

Collaborate with Quality and Software to develop configuration management process

Aug 2011 – July 2013 WellPoint Health Insurance Carlsbad, California Sr. Project Manager (contract)

WellPoint, a Fortune 50 company, is the largest health plan company in Blue Cross / Blue Shield system.

Responsible for Enterprise Healthcare Exchange, a project to respond to government mandates for Affordable Care Act (Obama care). Served as Business Project Manager for activities in Virginia, Georgia, and New York.

Create project schedule and manage budget for the state programs

Manage approximately fifteen business resources in each state

Manage meetings to identify state requirements in each business program, including:

Prepare level of effort estimates for IT & Analytics group to determine systems impacts

Responsible for Medical Member Enhancement; a DW/BI project to provide data via tablet to clinicians.

Responsible for $900K budget and performance of a team of approximately 30 business and IT resources.

All team members work in a remote environment across the United States

Prepare LOE estimates for PMO gate review phase (Discovery, Planning, Execution)

Manage teams of developers and testers in Canada, Philippines, and US all in telecommute environment

Manage business resources assigned to project; schedule implementation and training activities

Weekly status reports to sponsors, program manager and enterprise PMO

March 2011 – August 2011 Medtronic (Medical Devices) San Diego, California Program Manager (contract)

Covidien is a Medical Device company with a focus on airway management products. I managed the Options Program, a subset of the project to create the next generation critical care ventilator. The program included responsibility for: Proximal Flow measurement; Capnography; Inspiratory Filter; Battery, and Nebulizer.

Serve as Core Team member for the Options team at Program Review meetings

Coordinate activities of Software, Logistics, Field Service, Quality and Engineering team members

Manage the engineering team from R &D; Mechanical, System Controls, Advanced Engineering

Assemble the project team and create schedules, deliverables and milestones for each project

Manage the vendor relationship, oversee budget, and h/w purchasing ( PCB, PCBA, Parts and Tooling)

Ensure Design History Files, Device History Records, and Device Master Record is maintained

Ensure adherence to SDLC, Design Control and Design Validation process

March 2010 – Feb 2011 SharePoint360 (Professional Services) San Diego, California Sr. Project Manager, Director of Service Delivery

SharePoint360, a Microsoft Certified Gold partner, is a software consulting and hosting provider creating unified, web-based technology services; primarily portal and document control systems. I was responsible for the performance of the professional services organization consisting of the PMO and the consulting staff of 20 resources. Accomplishments include:

Established a Project Management Office to establish process to monitor and control project performance

Created proposal development methodology to streamline RFP and SOW process

Developed a scalable project management methodology to accommodate various project types

Served at the Project Manager on key projects to build client relationships

Managed Data Center relocation project for City of El Cajon

Managed SharePoint implementations for the County of San Diego

Implemented customized SharePoint portals and enterprise content management

July 2007- Oct 2009 Insurance Company of the West San Diego, California

Program Manager - Infrastructure & Operations

I was responsible for successful completion of all data center projects. Following PMBOK-based methodology, managed risk, issues, budget, prepared project charters and schedules. Teams composed of both business and IT resources, and vendors in a matrixed environment. I was a member of the PMO team to implement MS Project Server and align service to ITIL disciplines across IT. Projects included:

Data Center Strategy– Coordinate planning for new architecture and site locations to provide HA and DR options while separating lower tier environments from production services.

Mainframe upgrade – Replace current hardware and operating system with z9 technology

Virtualization of applications

Disaster Recovery – Responsible to the CIO for developing DR capability for IT department. Managed IBM BCRS resources to complete first version of Disaster Recovery Plan. ICW utilized IBM Boulder, CO for IT recovery and their Costa Mesa venue for business recovery.

2004- March 2007 Computer Task Group (Professional Services) Indianapolis, IN

Elli Lilly and Company Indianapolis, IN

Sr. Project Manager - Global Medical Device IT (consulting for CTG)

As Program Manager at Eli Lilly, responsible for portfolio management, performance to schedule, team assignments, and resource planning for Medical Device IT business unit.

Medical Device Data Mart – Managed a local team of eight resources to develop a data warehouse for the Pharmaceutical Delivery business unit. Team consisted of 11 local analysts, developers and testers; plus France, Japan, Ireland, and Germany resources.

CRITRS – Managed team of four resources to develop a web-based application to facilitate the entry and tracking of change requests to meet FDA regulations on compliance and corrective / preventative action.

CAE File Management – The existing application did not allow for storage and rendering of several CAD drawing formats. The project was to replace the inadequate system with a new COTS product that would also align with DocuCorp and was 21 CFR Part 11 compliant. I inherited the project after multiple failures to launch. Team size was twelve IT and business resources; completed yearlong project one week behind.

2001-2004 Keane, Inc. (Professional Services) Indianapolis, IN

Senior Principal Consultant (at Eli Lilly & Company Pharmaceuticals )

As Sr. Principal Consultant, selected by Eli Lilly to become member of the Solution Center, an internal Lilly consulting group composed of professionals to assist Lilly in the completion of mission critical projects. Ensured adherence to corporate quality standards and validation guidelines. Managed and supervised Lilly employee team(s) of up to 15 software engineers, business analysts, testers, and technical writers. Created project management methodology and training for the enterprise PMO. Projects included:

Product websites – Situation was that Lilly product websites did not share any common appearance and confused users. I managed a project to redesign and implement common navigation and branding for all Lilly product websites.

Enterprise Knowledge Management – A pilot project that evaluated email scan tool to determine employee expertise areas. Integrated third party software and collaborated with three initial departments; decided to stop after early evaluation of pilot results.

PMO – as Senior PM, on the team that created the first Lilly PM methodology, and conducted training for the enterprise project management staff.

EDUCATION

University of California at Los Angeles - Bachelor Degree - History / Information Systems

PMI Certification - #503268

Scrum Alliance Certified Scrum Master

Consulting Training Courses:

Project Management Development Program

Productivity Management Training

Project Controls & Change Management

Project Estimating and Risk Management

Resource Management Skills Training

Application Management Methodology

Management Skills Training

Client Skills Training

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