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.