Principal Electro Mechanical Engineer

2 weeks ago


Milpitas, United States SysMind Tech Full time
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.

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