SUMMARY:

An Engineering Management / Project Management professional with extensive experience in leading Engineering Development, Testing, Risk Management and Quality efforts. Skilled in Software Development Life Cycle (SDLC), Hardware/Software Testing, RF Testing, Quality Assurance, Software Verification & Validation, Process Validation, Networking, New Product Development, CAPA and FDA Remediation Efforts; With 23 Professional LinkedIn recommendations from previous employers.

TECHNICAL SKILLS:

KEYWORDS: PROJECT MANAGEMENT, ENGINEERING, SOFTWARE DEVELOPMENT LIFECYCLE (SDLC), SCRUM MASTER, CSQE, SIX SIGMA, QUALITY CENTER, SOFTWARE QUALITY, MBA, PMP, BSEE, CCNA, FDA, VALIDATION, VERIFICATION, RATIONAL ROSE, TFS, IBM DOORS, BUGZILLA, JIRA, MS PROJECT, DOCUMENT LOCATOR, MEDICAL DEVICE, VSAT, ENGINEERING MANAGER, DIRECTOR, COMPLIANCE, REGULATORY, REMEDIATION, REQUIREMENTS MANAGEMENT, TRACEABILITY, IEC 62304, IEC 60601, CFR 21 PART 11, ISO 1348

PROFESSIONAL EXPERIENCE:

Sr. Software quality / Risk Management remediation

Confidential, San Diego, CA

Responsibilities:

• Effectively lead project teams in a collaborative environment, completing project deliverables per target timelines and requirements.
• Participate in and /or oversee all design and process validation activities required for assigned projects.
• Delivered project 483 remediation efforts along with 510k submittal with cross functional team successfully.
• Identification / Mitigation of Software Defects and Risk related hazards and harms.

Program Manager / Scrum master

Confidential, Acton, MA

Responsibilities:

• Effectively lead project teams in a collaborative environment, completing project deliverables per target timelines and requirements.
• Participate in and /or oversee all design and process validation activities required for assigned projects.
• Acted as the internal liaison between engineering, marketing, manufacturing, RA/QA and sales management for the purpose of scheduling projects, driving the timely launch of projects, budgeting resources, and reporting on the progress of several projects that are simultaneously being prepared for commercialization. Engaged externally with various teams to support innovative commercialization efforts.

Engineering Manager / Principal Engineer

Confidential, Clinton, MA

Responsibilities:

• Arthroscopic RF Generator Managed Engineering Resources in Development / Test, Defect Resolutions, Triage, and Resolution.
• Assessed the condition and quality of software builds, releases, and bug fixes and creation of Validation Summary Report.
• Risk Management, Requirements Management, Acceptance Criteria, Technical Design. Adherence of IEC 62304 Standards.
• Create detailed test plans, and test strategies to meet project goals, while improving of the quality of product.

Software remediation Lead / MANAGER

Confidential

Responsibilities:

• Software Requirements Management, Compliance of IEC 62304 standards, Guide / Improve SW development and processes.
• Provide current industry standards and Testing of Software
• Requirements creation, and approval within new product development projects for complex embedded electro - mechanical projects
• Configuration and Implementation of Defect Tracking Tool, and updating of corporate SOP and SW Design and Testing Protocols

Software Project Manager

Confidential, Tampa, FL

Responsibilities:

• Direct responsibility for global project execution through the project’s entire life cycle
• Actively lead the planning process, project stages and customer engagement throughout the implementation
• Drive collaboration between internal functional teams and client to achieve milestones and deliverables
• Ensures projects are delivered within scope, within goals and deliverables in accordance with governing Master Services Agreements and Statements of Work

Software remediation Lead / manager

Confidential, Concord, CA

Responsibilities:

• Tracking of SW development requirements to IEC 62304, Guide SW development while creating new developmental processes.
• Provide current industry standards and techniques in SW development, Requirements Management, and Testing Writing and reviewing of requirements, SW V&V, SW tools, etc.
• New Product Development projects for complex electro-mechanical devices with embedded software, Configuration and Implementation of Defect Tracking Tool (JIRA), and updating of Corporate SOP and SW Design and Testing Protocols

sr. rEMEDIATION Lead

Confidential, Mason, OH

Responsibilities:

• Isolator Synergy Ablation System: Risk Management Remediation Effort-Provides guidance and control directives regarding remediation activities required to continue production.
• Resolve critical issues remediation effort to ensure resolution and adherence of FDA standards.
• Write and review SOPs, Test Methods, Work Instructions, Deviations, CAPA’s, Change Controls and Risk Management Procedure and Documentation.

Sr. Software quality ENGINEER / New Product Dev.

Confidential, Largo, FL

Responsibilities:

• Apply SDLC and Agile Software Quality Assurance techniques, Requirements Creation, Acceptance Criteria, Technical Design. Adherence of IEC 62304 Standards.
• Create detailed test plans, and test strategies to meet project goals, while improving of the quality of product software.
• Updating and creation of Company SOP’s
• Managed Engineering Resources in Development / Test, Defect Resolutions, Triage, and Resolution. Assessed the condition and quality of software builds, releases, and bug fixes and creation of Validation Summary Report. Risk Management, CAPA Investigation and Resolution. Active member of company Steering Committee
• Electrosurgical Power Tools: Provide direction, guidance, review and remediation of client’s processes
• CAPA Investigation of Root Cause, Execution and Resolution. FMEA Reports, Process Risk Mitigation Plans and Process Validation Plans. Reviewed, amended, and wrote applicable SOP's; cGMP, FDA compliance, & Process Verification Efforts
• Create detailed test plans, and test strategies to meet project goals

Engineering Manager

Confidential, Tampa, FL

Responsibilities:

• Responsible for supporting and assuring the completion of the validation and process engineering project milestones
• Creation of master validation plan and timelines; Oversaw the Validation Engineering Group, Software Developers, Electrical Engineers and Quality Assurance in project planning, execution and validation processes;
• Collaborate with Director of Engineering in identifying and resolution of product defects, Project Progress and Timelines. Support and integration of new projects

Sr. Software QUAlity rEMEDIATION Lead

Confidential, Miami, FL

Responsibilities:

• Create and supervise the implementation of test plans, protocols and activities
• Requirements Management and Traceability; ensured the test process & documentation conformed to requirements and IEC62304
• Develop test protocols, implement test tools and supporting infrastructure, and perform hands-on testing

Sr. Technical project manager

Confidential, St. Petersburg, FL

Responsibilities:

• Development of Project Timelines, responsible for developing SOW, business proposals, financials, and managing medium complex medical device projects globally, & ensuring all of the project's technological requirements and / or objectives are met
• Managing Project’s Key Success Indicators, scope, quality, time and cost constraints.
• Project Risk/Design Reviews were conducted to ensure all FDA/Manufacturing guidelines are met; Communication Management of all stakeholders.
• Forecasting project budget and resource needs, schedule, quality, scope management, and customer satisfaction