Project Manager / Manufacturing Engineer

DAVRON CV: Candidate 3823790

PMP-CERTIFIED PROJECT MANAGER & MANUFACTURING ENGINEER | CAPITAL EQUIPMENT, AUTOMATION, MEDICAL DEVICES

Core Expertise

• Leading cross-functional teams for capital equipment and automation projects in regulated manufacturing environments.
• Managing full project lifecycle from RFQ and vendor selection through procurement, installation, and validation.
• Executing FDA, ISO 13485, EU MDR, and GMP-compliant development, validation, and design-transfer activities.
• Applying PMP and Lean Six Sigma methods to streamline processes and reduce cycle time (7% improvement).
• Driving risk, change, and documentation control with proactive escalation to protect scope and schedule.

Project Background

• Delivered capital equipment and pharmacy automation projects valued between $200K and $1.5M under regulated controls.
• Led projects spanning three months to two years, frequently managing three to four concurrent initiatives.
• Coordinated engineering, quality, suppliers, logistics, and operations while serving as primary client-facing contact.
• Developed RFQs, quotations, procurement packages, and standardized project templates incorporating regulatory KPIs.
• Oversaw commissioning, installation, IQ/OQ/PQ validation, and manufacturing transfers for medical device systems.

Key Skills

• Project management practices including PMP, phase-gate reviews, Agile, and Scrum methodologies
• Process improvement using Lean Six Sigma tools, value stream mapping, and waste reduction
• Validation and regulatory compliance: IQ/OQ/PQ, FDA 21 CFR 820, ISO 13485, EU MDR
• Project and reporting tools: MS Project, Smartsheet, Advanced Excel, Power BI, SAP Ariba
• Engineering design and analysis: SolidWorks, AutoCAD, Codeware COMPRESS

Education

• M.S., Project Management — Northeastern University
• M.Tech., Manufacturing Management — Birla Institute of Technology and Science
• B.Tech., Mechanical Engineering — JNTUH

Awards & Recognition

• Project Management Professional (PMP) — Project Management Institute
• Lean Six Sigma Green Belt
• Google Project Management Certificate

Why Interview this Candidate?

They are a PMP-certified project manager and manufacturing engineer with 8+ years delivering capital equipment, pharmacy automation, and medical-device projects in regulated environments. Proven ability to manage projects valued $200K–$1.5M, lead cross-functional teams, and execute compliance-focused validation and design-transfer activities. Strong client-facing communication, risk management, and Lean-driven process improvement skills enable immediate impact on capital-equipment or pharmaceutical manufacturing initiatives.