NPI Process Engineer 2

Title: NPI Process Engineer

Location: Irvine, CA

Job Type: Fulltime Permanent Role

Salary Range- $80,000-$90,000 a year + Benefits

Job Description

NPI Process Engineer

Must Have Technical/Functional Skills

• Experience supporting product development/New Product Development (NPD) activities is preferred.
• Design and develop electro-mechanical systems and components.
• Perform system integration of mechanical and electrical parts.
• Identifying and using stepper motors, drivers, sensors using PLC programming in design.
• Under limited supervision, performs mechanical, electromechanical, and developmental design duties in New Product Development engineering, where some judgment is required.
• Experience with industrial automation, robotics, or precision instruments is a plus.
• Strong experience with SolidWorks/CAD software and GD&T.
• Must possess knowledge of good manufacturing practices and documentation, preferably in the medical industry.
• Knowledge of ISO 13485, Medical Device Regulatory Standards, MDD, and MDR.
• Knowledge of statistical analysis and design of experiments (DOE) preferred.
• Knowledge of computer programs.
• Excellent interpersonal communication, organizational, planning, and project management skills.
• Personal computer skills, Microsoft Project, Windows applications including word processing, project planning, presentation, e-mail, web browsers, and spreadsheet software.

Roles & Responsibilities

• Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations and corporate procedures and guidelines, the duties and responsibilities for this position are:
• Identifies, designs, and develops the necessary equipment related to new product development.
• Studies existing processes to implement improvements for new products.
• Implements automation in processes and tools.
• Responsible for preparing and managing specifications.
• Assists technicians and engineers with unusual problems and is responsible for purchasing and designing equipment that meets safety and environmental requirements.
• Performs process and product validation activities.
• May supervise, coordinate, and technically review the work of a limited group of technicians.
• Responsible for communicating business-related issues or opportunities to the next management level.
• Performs other duties as assigned.

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