Demo

Industrial Manufacturing Engineer

Whitridge Associates
Sudbury, MA Full Time
POSTED ON 1/30/2025
AVAILABLE BEFORE 4/28/2025

Our client, a leader in the medical device industry, is seeking a Senior Industrial Manufacturing Engineer to join their dynamic team. This role focuses on designing, optimizing, and implementing high-performance manufacturing equipment for precision coronary catheter devices. You’ll play a key role in both new product introduction (NPI) and sustaining engineering, ensuring efficiency, reliability, and cost-effectiveness in production.

Key Responsibilities

  • Serve as the subject matter expert for equipment design, ensuring best practices and high-quality standards.
  • Collaborate with process development, R&D, and Quality teams to define equipment strategy and direction.
  • Lead feasibility studies, process selection, tooling / fixture design, and coordination with third-party equipment fabricators.
  • Develop zero-defect manufacturing processes, utilizing Poke Yoke, statistical process control, predictive maintenance, and other quality control techniques.
  • Drive design transfer to manufacturing, ensuring seamless integration of new processes and equipment.

Required Qualifications

  • Bachelor’s degree in Mechanical, Electrical, or related Engineering field.
  • 10 years of experience in the industry, preferably within ISO 13485 or ISO 9001 medical device manufacturing.
  • Proven expertise in medical device assembly equipment design, from manual assembly aids to complex automation.
  • Strong experience managing relationships with third-party design and fabrication providers.
  • Hands-on experience in equipment controls programs, calibration, maintenance, and qualification.
  • Knowledge of lean manufacturing and workstation design to support efficient production flow.
  • Excellent technical and interpersonal communication skills, with the ability to work both independently and collaboratively.
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