Senior Process Development Specialist

7 days ago


South San Francisco, California, United States MindSource Full time
Job Summary

We are seeking a highly skilled Manufacturing Process Engineer to join our team at MindSource. As a key member of our process development team, you will be responsible for providing innovative solutions to support the development of combination drug delivery devices for parenteral pharmaceutical therapeutics.

Key Responsibilities
  • Process Engineering: Develop and implement high-volume manufacturing processes and methodologies to support clinical and commercial production activities.
  • Quality System Compliance: Ensure adherence to quality standards and regulations, including design controls and risk management.
  • Design Controls: Lead the development and implementation of design controls to ensure the quality and safety of our products.
Requirements
  • Education and Experience: Bachelor's or Master's degree in Engineering, with a focus on Mechanical Engineering or a related field. Minimum 3-7 years of experience in the industry or academia.
  • Technical Skills: In-depth knowledge of high-volume manufacturing processes and methodologies, including plastic molding and mechanical assembly. Experience with control systems, statistical data analysis, and technical report writing.
  • Leadership and Collaboration: Proven ability to lead project planning, resource management, and liaison with engineering and manufacturing resources. Strong expertise in risk management tools and ability to assess changes and non-compliances.


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