Skills required:
Familiar with root cause analysis tools, Risk management (ISO 14971), Quality Management System (ISO 13485)
Supplier management, Electromechanical system, DFM,
Six sigma, IEC 60601-1, IEC 61010-1, IEC 60950-1, IEC EN 61326, Program Management, Team Management.
Knowledge in NPD lifecycle, Process Improvement.
Roles & Responsibilities:
•Project manage and supervise team to successfully deliver high quality discipline projects in line with project lifecycle.
•Define & resolve complex issues to improve customer experience, recommend, guide, and implement business strategies, technical solutions through innovation and science.
•Be a technical expert for Customer Experience Engineering; ability to make the complex clear by having a diverse knowledge of engineering principals and root cause resolution techniques to solve technical problems based on customer needs.
•Participate in Design Thinking and immersive user research to identify opportunities for better brand experiences.
•Translates requirements from multiple departments - Site Quality Directors, R&D, Complaint Handling, Data Analytics, Product Safety, Clinical/ Medical Affairs, Field Services, Clinical Education and Medical Safety Officer to achieve root cause resolution.
•As individual technical expert need to technically supervise other engineers or technicians.
•Interact directly with customers (Surgeons) to determine and identify unmet needs to support lifecycle enhancing improvements.
•Provide technical expertise & ensure customer requirements throughout lifecycle of new product development, commercialization.
•Risk Management activities over-sight throughout the NP lifecycle (Mfg.
Readiness Assessments, pFMEA, Control Plans).
•Continuously identify and expand network for new technologies and quality standards.