About this Candidate
DAVRON CV: Candidate 479450
MANUFACTURING ENGINEERING & OPERATIONS LEADER | FDA-COMPLIANT MEDICAL DEVICE MANUFACTURING
Core Expertise
- Manufacturing operations leadership across multi-site facilities, overseeing production, maintenance, facilities management, and cross-functional teams.
- Regulated manufacturing compliance expertise including FDA cGMP, ISO 9001, and ISO 13485 implementation and audits.
- Engineering change control, BOM and routing management, and governance of MRP/ERP manufacturing documentation.
- Lean manufacturing practitioner skilled in 5S, value-stream mapping, takt-time development, and continuous improvement.
- Capital equipment planning, automation design, prototyping, and preventive maintenance program development and execution.
Project Background
- Directed multi-site manufacturing and engineering teams across two plants supporting roughly 100 employees and dual shifts.
- Led design, prototyping, and deployment of semi-automated material-handling systems, expanded to six manufacturing units.
- Coordinated emergency recovery from a plant-wide air-compressor failure, securing temporary equipment and restoring production within four hours.
- Developed and implemented preventive maintenance programs that improved equipment reliability and decreased unscheduled downtime.
- Managed engineering documentation, Device Master Records, and change controls to maintain cGMP and ISO compliance.
Key Skills
- SolidWorks | AutoCAD
- Epicor | MRP | ERP systems
- Process automation | Equipment troubleshooting | Capital equipment
- Lean manufacturing | 5S | Value stream mapping | Takt time
- FDA cGMP | ISO 9001 | ISO 13485 compliance
- Engineering change control | BOMs | Routings | Document control
Education
- B.S., Industrial Technology — State University College at Buffalo
Awards & Recognition
- Military service awards including achievement and good conduct recognitions
Why Interview this Candidate?
A seasoned manufacturing engineering leader with deep experience in FDA-regulated medical device operations, process automation, and equipment reliability. Demonstrated ability to restore critical production quickly, deliver capital and automation improvements, and achieve measurable cost savings through Lean initiatives. Ready to apply multi-site leadership and compliance expertise to improve uptime and operational efficiency.
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