Project Manager Coordinator

STEVE R. MEDINA, CAPM

Rocklin, CA ***** 916-***-**** ********@*****.***

linkedin.com/in/steve-medina-project-manager

Project Management Professional

Results-driven Project Manager with demonstrated experience in the manufacturing industry including experience in the highly regulated medical device industry to develop world class medical and industrial products. A proven history of success bolstering business objectives for growth-orientated organizations and delivering value to customers with innovative products and solutions.

Core Competencies

Project Management Project Risk Project Coordination Resource Allocation Stakeholder Management Budget Management Engineering Management Production Management

Professional Experience

Beckman Coulter-Contract worker November 2023-Present

Program manager for IVD instrument product development.

Managed team to compile legacy product 510(k) submission documentation.

Managed EMC recertification testing: Acquired prototype parts, scheduled testing, user manual changes.

Managed new component vendor development agreement. Created/managed PO requisitions and payments.

Organized cross functional teams to conduct sub-system Design Input Requirements reviews.

Created VPM project schedules manually and on Miro boards. Maintained risk register, action items, issue tracker and resource demand in Smartsheets.

Led cross functional problem-solving Tiger Team with weekly updates to Management.

Philips (acquired Volcano in 2016), Rancho Cordova, CA February 2016 – July 2023

Senior Project Manager

Led new product development projects consisting of project planning, scheduling, budgeting, user & engineering design requirements, multi-level design outputs, design verification/validation, and transfer to production/service activities.

Managed multiple sustaining, design change and new product development projects simultaneously.

Effective team builder, team leader, conflict and risk manager focused on team effectiveness and efficiency.

Managed multi-national project teams across 3 continents.

Supervised product change requisitions, change orders/document control, assembly BOMs, field service kits, supplier changes, and completed cost reduction and margin expansion projects.

Created and validated new packaging & labeling designs. Managed mechanical reliability test projects.

Conducted project phase gate reviews and engineering design reviews.

Adhered to Project Governance/PMO requirements, presented project dashboards to project review committees.

Managed multiple Safety & EMC IEC 60601 certification projects with UL & TUV.

Worked within ISO 13485 QMS & ISO 14971 Risk Management standards in adherence to FDA 21 CFR part 820, compiled REACH/ROHS3 declarations for restricted substances database.

Compiled, audited and maintained Design History Files and DMRs. Supported internal and external FDA audits.

Sustaining Engineering Manager

Managed electrical and mechanical engineers and cross functional sustaining team (avg. 12-15 people) to support console production with new/replacement parts, maintaining safety & EMC test file certifications, process problem solving, and adopting new global regulatory requirements.

Created the Hardware Sustaining Team to support daily manufacturing and 10K+ console systems installed worldwide.

Directly managed electrical and mechanical engineering resources for product sustaining allocation.

Managed end-of-life component replacements and design changes for production and service teams.

Served as member of product complaint review board to monitor and resolve customer complaints.

Assisted the transfer of in-house manufacturing to contract manufacturers resulting in $1M annual savings.

Developed/managed department budgets, hired and onboarded new employees, conducted annual performance reviews, and developed/tracked annual employee performance goals in Workday.

Volcano Corp., Rancho Cordova, CA 2006 – February 2016

Project Manager

R&D Project Manager for new product development. Duties include project planning, scheduling and progress reporting. Multiple project tracking, bottleneck mitigation, design review, resource assessments and department training. Cross-functional project team coordination/consulting, assisting in the development of product documentation and meeting regulatory requirements. Compiled, audited and maitaned Design History Files.

Project meeting leader, procedure writing, CAPA management, Change Review Board representative, change order approver, PO/shipping requisitions, capital equipment procurement, R&D lab/equipment manager, and R&D facility relocation management.

Proficient in MS Word, Excel, MS Project, & PowerPoint. Good presentation skills to all levels of the organization.

Additional Relevant Experience

CPI EIMAC, San Carlos, CA

Manufacturing Engineer Production Supervisor Internal auditor

Marchi Associates, Redwood City, CA

Production Supervisor Facilities expansion and management

Education

Bachelor of Science (BS) in Industrial Technology - Manufacturing Concentration,

Minor: Organization and Management,

San Jose State University, San Jose, CA

Project Management Institute CAPM Certification Nov 2023

Certificate # 3712339

Certification: ISO 9001 Standards and Auditing

Five-day Lead Auditor training for ISO 9001 certified quality systems,

Excel Partnerships – San Jose, CA

Associate of Science (AS) in Engineering,

Associate of Science (AS) in Mathematics

Associate of Arts (AA) in University Studies

Canada College – Redwood City, CA

Honors

Volcano Corporation Founder’s Award

San Jose State Honor Student

Cañada College Honor Student

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