Manufacturing Process Engineer

3 weeks ago


Augusta, Maine, United States Planet Pharma Full time

Job Summary:

Planet Pharma is seeking a skilled Manufacturing Process Engineer to join our team. As a key member of our manufacturing team, you will be responsible for developing and implementing manufacturing processes, qualifying changes to products, and running validations.

Key Responsibilities:

  • Develop and implement manufacturing processes to ensure high-quality products
  • Qualify changes to products and run validations to ensure compliance with FDA, GMP, and ISO regulations
  • Work closely with R&D and manufacturing teams to capture and interpret design intent
  • Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis
  • Coordinate with suppliers and external resources needed in developing and implementing new processes

Requirements:

  • 3-5 years of related work experience in a medical device manufacturing environment
  • Strong knowledge of Design for Manufacturing (DFM), Design of Experiments (DOE), and product/process
  • Experience in Failure Mode and Effects Analysis (FMEA) and Lean Manufacturing
  • Excellent written, verbal, and interpersonal skills
  • Ability to effectively interact with all levels of employees and management

Education:

Bachelor's degree in Mechanical Engineering, Electrical Engineering, or Industrial Engineering



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