Engineering Project Manager – Tekniplex

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Location
Candidate No.
3808156

About this Candidate

DAVRON CV: Candidate 3808156

SENIOR ENGINEERING LEADER | MEDICAL DEVICES, NPD, MANUFACTURING AUTOMATION

Core Expertise

  • Engineering leadership for FDA-regulated medical devices spanning concept through commercialization.
  • New Product Development management with cross-functional teams, validation, and regulatory compliance.
  • Manufacturing automation and capital equipment development for scalable production systems.
  • Design and development of catheter, balloon, and delivery systems for specialty devices.
  • Supplier development, global sourcing, and technical vendor partnerships for complex assemblies.

Project Background

  • Directed engineering strategy for large commercial vertical-farming automation and proprietary production systems.
  • Led development of automated pharmaceutical and vaccine-production equipment with rigorous validation controls.
  • Managed orthopedic tissue-product and surgical-instrumentation development from concept through regulatory commercialization.
  • Founded and operated a medical device distribution and consulting firm serving orthopedic and spine markets.
  • Oversaw multidisciplinary teams through prototyping, commissioning, reliability improvements, and production deployment.

Key Skills

  • CAD | Mechanical design | Prototyping | Design reviews
  • Regulatory & Quality | ISO 13485 | cGMP | FDA Design Controls | Validation
  • Continuous Improvement | Six Sigma Green Belt | DOE | SPC | Taguchi Methods
  • Manufacturing Automation | Equipment design | Controls integration | Capital procurement
  • Catheter, balloon, and delivery system design | Orthopedics & sports-medicine devices
  • Supplier development | Global sourcing | Costing, proposals, and commercialization

Education

  • M.S., Engineering Management — New Jersey Institute of Technology
  • B.S., Mechanical Engineering — New Jersey Institute of Technology

Awards & Recognition

  • Six Sigma Green Belt certification
  • Named inventor or co-inventor on multiple U.S. patents covering medical and manufacturing innovations

Why Interview this Candidate?

They are a seasoned engineering leader with 35+ years developing FDA-regulated medical devices and leading multidisciplinary teams through NPD, validation, and commercialization. Hands-on with CAD and manufacturing automation, they excel at mentoring engineers and driving scalable production solutions, ready to return to full-time engineering leadership.

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