Fulltime Hire

2 weeks ago

Irvine, United States Siri InfoSolutions Inc Full time
Job DescriptionJob Description

Process Engineer

Irvine, CA

Fulltime Hire

Job Skills and Responsibilities:

Relevant Experience

3+ years of medical device industry experience in design control and/or project engineering

Must Have Technical/Functional Skills

  • Knowledge about GxP
  • Strong creative, analytical and problem-solving skills.
  • Proficient at interpreting data and putting that data into a report.
  • Experience in writing software specification documents
  • Process experience, ability to observe and understand manufacturing processes.
  • Excellent Interpersonal / communication skills, Organizational / planning and Project management 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.)
  • Good experience in Validation (IQ, OQ & PQ).
  • Ability to read engineering drawings, GD&T, terminology, schematics.
  • In-depth knowledge of design of medical devices preferred.

Experience Required

3+ years of experience & demonstrated proficiency in Process engineering & providing ongoing technical support is preferred with evidence of continued self-development.

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:
  • Programming, Setup, Update MOP
  • Exceptional in validations, Executing DOEs and characterizations that build to robust validation Work in a cross-functional team environment.

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