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Sr. Manufacturing Engineer

Company: Freudenberg Group
Location: Carpinteria
Posted on: March 13, 2023

Job Description:

Empowering people, creating technology.


  • Review proposed new tooling/tooling modifications and repairs to determine the level of validation necessary and coordinate with other functional departments to develop and implement validation test plans.
  • Develop validation protocols and reports (IQ/OQ/PQ - Installation Qualification, Operational Qualification, Performance Qualification) and provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.
  • Prepare procedures related to process, equipment, test methods and product
  • The investigation of EO/DCN(Engineering Change/Document Change Notice) received in the Manufacturing Engineering department, their rejection or approval, development and implementation of any process changes and proper documentation of any such changes.
  • Initiate improvements in current manufacturing methods and process to improve part quality, schedule performance and to reduce manufacturing costs.
  • Initiate, control and execute validation processes and procedures for engineering as required by FDA.
  • Strong in authoring validation strategies, DOE, FMEA risk assessments, , technical completion reports, data analysis and completion reports.
  • Ability to support manufacturing, engineering and product development to implement new or changing processes.
  • Ability to review production data and provide recommendations for process control and process parameters. Qualifications:
    • Engineering Bachelor of Science degree, preferably Industrial, Manufacturing or Mechanical Engineering.
    • Minimum 4 to 7 years experience working as a process, validation, tooling or manufacturing engineer in a manufacturing environment. Must have at least 3 years experience writing validations (from start to finish)
    • Strong in authoring validation protocols and reports, DOE, FMEA risk assessments, , technical report authoring, strong statistical data analysis and recommendation reports.
    • Must understand the following regulations: FDA regulations 21 CFR 820; ISO 13485; ISO 14971, GMP
    • Knowledge of multiple types of silicone injection molding machines, ultrasonic equipment, advanced measurement systems preferred.
    • Technical experience in tooling and process validation.
    • Project management skills
    • Demonstrated oral and written communication skills and presentation skills.
    • Accurate and attentive to detail.
    • Good written and spoken communication skills.
    • Work with minimal supervision.
    • Make educated decisions based on data.
    • Mechanical aptitude. Preferred Qualifications:
      • 2D/3D CAD and Solid Works experience.
      • Six Sigma Green Belt or Black belt Certification.

        The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

        Freudenberg Medical LLC

Keywords: Freudenberg Group, Santa Barbara , Sr. Manufacturing Engineer, Engineering , Carpinteria, California

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