Process Engineer 2

Role         ::         Process Engineer 2

Location ::          Irvine, CA

Type        ::          Fulltime

Job Description

Must Have Technical/Functional Skills

• GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs
• Knowledge in Experiment design and SPC
• Management of statistical procedures
• Strong creative, analytical and problem-solving skills.
• Comprehension of standard costs and work standards
• Proficient at interpreting data and putting that data into a report
• Experience in PLM Tool (Windchill)
• Process experience, ability to observe and understand manufacturing processes
• Excellent Interpersonal / communication skills, Organizational / planning skills preferred
• Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
• Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)

Roles & Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:

• Identifies, designs and develops the necessary equipment related to new product development/new product introduction.
• Performs material tests.
• Studies the existing processes to plan and implement improvements.
• Responsible for preparing and managing specifications.
• Assists technicians and engineers about unusual problems. 
• Responsible for purchasing and designing equipment that meets safety and environment requirements.
• Perform Process Development, Tool Development activities
• Performs activities of process/product/ Equipment validation.
• Creation of ECOs to upload documentation changes to PLM system (Windchill) as per the requirement.
• Can supervise, coordinate and technically revise the work of a limited group of technicians
• Know & follow policies & procedures related to work activities performed in area of responsibility
• Complete training in area of responsibility within allowed time-period and periodic retraining in areas

Generic Managerial Skills, If any

• Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.
• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. 
• Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
• Ability to understand and follow complex written procedures is required.
• Ability to function in a team environment and deliver on team objectives is required.
• Ability to make decisions and solve problems while exhibiting situational judgement.