Senior Specialist, Drug/device Combo Products Engineer - Hybrid

Merck Merck · Pharma · NJ

Senior Specialist, Drug/Device Combo Products Engineer at Merck, focusing on the development, manufacturing, and assembly of medical devices and combination products. Responsibilities include hands-on factory floor work, supplier collaboration, process interrogation, and supporting quality control strategies. Requires expertise in vision inspection systems, PLC programming, and mechanical troubleshooting within a regulated industry.

What you'd actually do

  1. SME level knowledge of combination product assembly system vision inspection processes and development.
  2. Has worked with Cognex, Keyence or comparable vision systems with experience in identifying appropriate lensing, lighting and integration of camera inspection systems on equipment
  3. Able to develop vision jobs using Insight Explorer or comparable vision system development environments
  4. Competent in reading wiring diagrams and has experience in debugging wiring issues on manufacturing equipment
  5. Knowledgeable in deciphering PLC programs (Ladder Logic (LD), Structured Text (ST), Function Block Diagram (FBD), Sequential Function Charts (SFC), and Instruction List (IL)) and can do some program changes

Skills

Required

  • Combination Products
  • Detail-Oriented
  • Deviation Management
  • Device Development
  • Driving Continuous Improvement
  • Electrical Engineering
  • Ethical Compliance
  • Function Block
  • GMP Documentation
  • Injection Moldings
  • ISO 13485 Medical Devices
  • ISO 14971 Risk Management
  • Medical Device Manufacturing
  • Plastic Injection Moulding
  • Product Development
  • Product Lifecycle Management (PLM)
  • Prototyping
  • Quality Management Systems (QMS)
  • Risk Management
  • Root Cause Analysis (RCA)
  • Structured Text
  • Teamwork
  • Vision Systems
  • Working Independently

Nice to have

  • Knowledge of injection molding and assembly of plastic products including design for low and high-volume manufacturing and assembly
  • CAD design, including knowledge of SOLIDWORKS and 3D printing.
  • Prototyping and ability to fabricate custom fixtures for assembly and testing.

What the JD emphasized

  • minimum 6 years of regulated industry experience