NPI Process Engineer

Siri InfoSolutions Inc; Irvine (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

Siri InfoSolutions Inc. in Irvine, CA is seeking an NPI Process Engineer for on-site, full-time work. You will design electro-mechanical systems, integrate mechanical and electrical parts, and drive automation in new product development.

The role requires PLC-driven design experience and working knowledge of ISO 13485 and regulatory standards. Excellent CAD skills (SolidWorks) and GD&T, plus strong project management and communication abilities, are essential to ensure compliant, timely product

Qualifications

• Must Have Technical/Functional Skills
• Knowledge and experience in product development/NPD 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, developmental Design duties in New Product Development engineering.
• 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 skills, Organizational / planning and Project management skills
• Personal computer skills, Microsoft Project, Windows: word processing, project planning, presentation, e-mail, web browsers & spreadsheet software.

Responsibilities

• Identifies, designs, and develops the necessary equipment related to new product development.
• Studies the existing processes to implement improvements on new products.
• Implement the automation in process and tool.
• Responsible for preparing and managing specifications.
• Assists technicians and engineers about unusual problems. Responsible for purchasing and designing equipment that meets safety and environmental requirements.
• Performs activities of process/product validation.
• Can supervise, coordinate, and technically revise the work of a limited group of technicians.
• Responsible for communicating business related issues or opportunities to next management level.
• Performs other duties assigned as needed.

Skills

Interpersonal skills

Communication skills

Project management

Organizational skills

Problem solving

Team collaboration

Tools

SolidWorks

CAD software

GD&T

Microsoft Project

Windows MS Office

Job description

Job Title: NPI Process Engineer

Location: Irvine, CA (Onsite)

Fulltime

Roles & Responsibilities:

Must Have Technical/Functional Skills

Knowledge and experience in product development/NPD 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, developmental Design duties in New Product Development engineering, where some judgement 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 skills, Organizational / planning and Project management skills

Personal computer skills, Microsoft Project, Windows: word processing, project planning, presentation, e-mail, web browsers & 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 the existing processes to implement improvements on new products.

Implement the automation in process and tool.

Responsible for preparing and managing specifications.

Assists technicians and engineers about unusual problems. Responsible for purchasing and designing equipment that meets safety and environmental requirements.

Performs activities of process/product validation.

Can supervise, coordinate, and technically revise the work of a limited group of technicians.

Responsible for communicating business related issues or opportunities to next management level.

Performs other duties assigned as needed.