Industrial Manufacturing Engineer
Whitridge Associates - portland, ME
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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 ResponsibilitiesServe 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, toolingfixture 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 QualificationsBachelor'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.
Created: 2025-02-21