Principal Product Development Project Manager Resume Naples, FL - Hire IT People

SUMMARY

Results oriented leader with a proven track record of implementing project management best practices and coordination of cross - functional teams and activities in medical device and regulated industries.
I am a certified project management professional focused on delivery of successful project outcomes and achievement of established business goals.

PROFESSIONAL EXPERIENCE

Confidential

Principal Product Development Project Manager

Responsibilities:

Member of product management oversight committee for CRDN operating unit, as PMO representative.
Contributed to development of operating unit annual operational plan for FY2024.
Led cross-functional team in support of EU MDR submission project for 18 product lines.
Developed the operating processes used in remediating and submitting product design files for regulatory approval.
Developed operating model used in maintaining design and registration files through their regulatory lifecycle.
Refined and improved processes through use of lessons learned and feedback from stakeholders at multiple levels of the organization.
Provided guidance to projects presenting updates and issues to oversight group.
Completed final product submission 4 months ahead of plan.
Successfully achieved certification for 10 product lines to date. Significantly reduced risk for remaining submissions.

Confidential - Naples, FL

Project Manager - Quality Assurance

Responsibilities:

Initiated and led major design file remediation project to final stage.
Responsible for all project planning and on-site oversight.
Established team organization and assignments for 20+ consultants.
Developed the Quality workflow processes for assessing and remediating design files to reduce regulatory compliance risks and aid new product development.
Served as Sr. Quality Engineer creating, reviewing, redlining and approving DHF documentation, including requirements, trace, FMEAs.
Provided regular updates to mid and senior level management.

Confidential - Round Lake, Illinois

Project Manager

Responsibilities:

Successfully launched multiple hardware and software updates for the nutrition compounding product family.
Led Electromechanical Devices Platform Core Team through product maintenance activities for infusion pump products.
Led multiple projects from initiation through design transfer to manufacturing for clinical nutrition business, scaling defined process as needed to appropriately fit specific project needs.
Led transfer of manufacturing lines to external manufacturers, ensuring supply continuity.
Managed annual budget for new product development and sustaining activities for automated compounding platform and pharmacy order management software.
Implemented new Project Initiation process for business unit R&D team.
Reported monthly to senior R&D and business leadership on status, issues, risks and budget performance.
Provided support during FDA audits of hardware and software CAPAs.

Confidential - Lake Forest, Illinois

Principal Analyst

Responsibilities:

Responsible for identification and delivery of systems to support the Global Regulatory Affairs business.
Managed team of 30+ global resources tasked with solution delivery consistent with business LRP goals.
Led ongoing projects with annual budgets of $6 million.
Managed stakeholder relationships, including quarterly updates to CIO.
Responsible for direct management and development of permanent staff members.
Led relationship building efforts between IT and Regulatory Affairs business.
Led efforts for the creation and management of software development documentation.

Confidential - Chicago, Illinois

Project Manager

Responsibilities:

Managed project schedules and daily project activities for insurance products.
Managed expenses associated with $1.7 million budget.
Led meetings and project reviews with cross-functional team members, senior management and stakeholders.
Worked with IT to monitor development, testing and deployment of technical solutions.
Worked with Marketing to manage creation, approval and distribution of marketing materials for new product rollout.

Confidential - Round Lake, Illinois

Project Manager / Sr. Principal Engineer

Responsibilities:

Responsible for managing projects within the Specialty Pharmaceuticals Franchise.
Coordinated 12 local and remote resources across multiple projects and CAPA efforts.
Led product End of Life activities for two product lines and associated disposable products.
Prepared and presented project stage gate presentations to executive management.
Provided support during audits of hardware and software CAPAs.