Manufacturing Operations Manager – Zephyrus

DAVRON CV: Candidate 3808371

MANUFACTURING ENGINEERING LEADER | MEDICAL DEVICE SCALE-UP, QUALITY & LEAN OPERATIONS

Core Expertise

• Manufacturing operations leadership in FDA-regulated medical device environments, driving compliance and throughput.
• End-to-end process engineering for scale-up from prototype to high-volume production with documented procedures.
• Continuous improvement and lean manufacturing champion using Kaizen, 5S, line balancing, and waste reduction.
• Quality systems and regulatory compliance: ISO 13485, APQP, FMEA, validations, and audit readiness.
• Cross-functional team leadership, mentoring engineers, and implementing best practices across manufacturing functions.

Project Background

• Scaled robotic medical device production from ~30 to ~150 units annually while improving manufacturability.
• Supported high-volume assemblies producing up to 500 units per day through line design and balancing.
• Led regulated process transfers between facilities including validations, calibrations, and SOP alignment.
• Reduced redundant inspections and optimized QC checkpoints to increase throughput and decrease cycle time.
• Developed manufacturing documentation, work instructions, and training to ensure process discipline and competence.

Key Skills

• Manufacturing Operations Management | Process Engineering | Scale-up
• Lean Manufacturing | Kaizen | 5S | Line Balancing
• Quality Systems | ISO 13485 | FDA Compliance | APQP | FMEA
• Continuous Improvement | Root Cause Analysis | SPC
• CAD & 3D Modeling | Manufacturing Layouts | Assembly Work Instructions

Education

• M.S., Manufacturing Management — Kettering University
• B.S., Industrial Engineering — Florida Agricultural and Mechanical University
• B.A., Applied Mathematics — Kentucky State University

Awards & Recognition

• ISO 13485 compliance and quality management system implementation experience
• Extensive experience in FDA-regulated medical device manufacturing and audit readiness

Why Interview this Candidate?

Seasoned manufacturing engineering leader with deep experience in medical device scale-up, quality systems, and lean operations. Proven ability to boost production capacity, reduce inspection steps, and lead cross-functional teams in regulated environments. Ready to lead Manufacturing Operations and deliver measurable production, quality, and cost improvements.