SUMMARY:

• Seasoned, analytical, and growth - driven professional, offering broad-based experience in project and program management, new product development and regulatory compliance in a complex engineering environment.
• Known for a strategic and proactive approach in developing project plans, implementing program strategy, directing team efforts, managing all phases of projects and overseeing overall program completion towards product launch.
• Effective at collaborating and establishing positive relationships with diverse teams and individuals.
• Equipped with well-defined organizational, communication, leadership, problem-solving, decision-making, multitasking, and technical skills.

AREAS OF EXPERTISE:

• Strategic Planning and Implementation
• Regulatory/FDA 510K Submission
• Project/Program Management Structure
• Design Control/ FDA 21 CFR Part 820/ ISO 13485:2016
• New Product Development Execution
• Complex Medical Device Projects/Program
• Cross-Functional/Core Team Leadership
• Technology & Process Improvement

PROFESSIONAL EXPERIENCE:

Confidential, San Diego, CA

Program Manager

Responsibilities:

• Took charge of large-scale new product development ( Confidential ) programs ranging from $2M to $25M budget, along with in-vitro diagnostics device with complex integration to the instrument, software, cloud, assay, clinical, and manufacturing under a regulated environment.
• Partnered with program sponsors, functional managers, and executives to establish the business case, program strategies, company priorities, a budget, a launch date, resource requirements, and a regulatory path.
• Launched a stage-gate system with program governance model and matrix Confidential phase deliverable.
• Chaired steering committee comprising of program sponsor and cross-functional leaders to oversee significant changes in the high-level program schedule, inter-departmental dependencies, program milestones, committed resources, program scope, cost, project risks/issues including discussions of mitigations and resolutions.
• Developed and directed a PMO structure encompassing project management process/methodology (PMBOK-Waterfall, Agile) project charters, project plans, communication plans, and status reporting.
• Provided to project managers and engineers relating to project schedules, critical paths, loading enterprise resources, scope management, phase-gate process, and design control.
• Implemented a Microsoft Project Online, functioned as project center dashboard for stakeholders, providing project health, percent completions, project information, performance analytics, and collaboration tool.
• Executed a comprehensive work plan using MS Project focusing on detailed work streams, phase-gate deliverable, milestones, dependencies, assigned resources, percent completions, and timeline view.
• Worked with the software team in Agile/Scrum process using Jira tools such as Bitbucket and Confluence. Used JAMA software to manage requirements and traceability.
• Collaborated with Project Managers, Engineers/Software leads, and Scientists in the development of subsystems: enclosures, optics, fiber network, laser, electronics, embedded firmware, robotics, software, cloud and algorithms, cybersecurity, assay, plastic molded consumables, and Human Factors/Usability.
• Established a working relationship with Quality Assurance, Regulatory, Product Marketing, Finance, Manufacturing, Purchasing, and external development partners to support overall program objectives.
• Engaged working with core teams completing design history files (DHF), including user needs marketing requirements (MRD), product requirements (PRD), design development plans (DDP), trace matrix, design input and output, design reviews and design transfer, verification, risk management, good manufacturing process (GMP) validation, labeling, consumable packaging, Instructions for Use (IFU), operation’s manual, process validation, DMR, and DHR .
• Implemented an Confidential execution and a PMO process which resulted in the on-time 90% completion of medical device Maverick 510K submission program Successful launch of the “First Confidential t” laboratory development testing (LDT), which has been delayed for three years On-time opening of CLIA Texas operations.

Confidential, CA

Program Manager

Responsibilities:

• Managed a large-scale manufacturing transfer of class III device from Midwest to a California facility under Operations/PMO management.
• Provided program direction to multiple complex cross-functional teams comprising of regulatory, quality assurance, facility construction, manufacturing, engineering, operations, quality control, sales, customer service, finance, process and equipment validation, information technology, and supply chain.
• Created a detailed project plan using Microsoft Project schedule and monitored progress daily.
• Collaborated with functional managers and cross-functional leaders, in resolving issues and project risks.
• Worked with project leaders in the transfer and delivery of Design History Files (DHF), Device Master Record (DMR), and Device History Record (DHR) documents.
• Communicated updates regularly and conducted gate reviews to provide executives with the current status of Operational, Quality, and Manufacturing “Readiness”.
• Brought savings of $500K by completing the manufacturing transfer program two months early which was accredited to close monitoring of project critical paths and risks.

Confidential, Irvine, CA

Project Manager/Engineer

Responsibilities:

• Provided and led project management of high-level disinfectant medical device capital equipment product developments covering new and sustaining engineering projects ranging from moderate to high complexity, involving electronics, fluidics, thermo-formed enclosures, firmware, unit accessories, consumables, and software. Executed multiple projects across R&D platforms.
• Managed approximately two large new product developments and dozens of product improvement projects.
• Partnered with senior management to ensure alignment of project with the company goals and priorities, commercial plan, product configuration strategy, resource plan including identification of project risks.
• Facilitated cross-functional core team project reviews taken part by R&D, quality, regulatory, operations, technical service, marketing, finance, chemistry, industrial design, and external development partners, discussing project integration, task barriers, resource issues, technical problems, gaps and disconnects, critical paths, problem-solving, and dependency requirements.
• Worked with software team within the Agile environment including labeling and packaging design team and technical service group for manuals and for a global launch.
• Participated and made contributions in creating the New Product Development Execution process.
• Actively conducted and attended design control phase reviews, DHF internal audits, Change Review Board meetings, CAPA presentation, and peer approvals for engineering change orders.
• Completed a successful product launch of a new capital equipment disinfectant system across five countries and initiated the next generation disinfectant program.
• Contributed to the completion of a comprehensive “New Product Development Execution” process increasing project performance by 30%

Confidential, Brea, CA

Project Manager

Responsibilities:

• Oversaw various therapeutic drug monitoring (TDM) corrective and preventive action (CAPA) assay projects including one Confidential assay development in all phases of projects.
• Generated project plans, schedules, and design control deliverable and led cross-functional core team project completion using an organized project management process.
• Presented slides for the leadership committee gate reviews and deep dive discussions.
• Played an integral role in completing a complicated CAPA project after three years of delay.

Confidential, Ontario, CA

Engineering Program Manager

Responsibilities:

• Managed an engineering product development and computer service group with clients from 500 Fortune companies from military, aerospace, commercial, and medical industries.
• Developed several engineering standard procedures (SOP). Involved in product design; Directed and supervised 12 engineers.
• Successfully attained project metrics of 90% on-time project delivery for clients.