Job Description
Job DescriptionTitle: 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.