Senior Process Development Engineer

2 weeks ago


Carlsbad, United States Bolt Medical Full time
Job Summary

We are seeking a highly skilled Process Development Engineer to join our team at Bolt Medical. As a key member of our engineering team, you will be responsible for designing, developing, and optimizing manufacturing processes to ensure efficient and high-quality production.

Key Responsibilities
  • Evaluate current manufacturing practices and identify areas for improvement.
  • Lead process development and optimization activities with a focus on Design for Manufacturing.
  • Collaborate with R&D and Manufacturing teams to ensure seamless integration.
  • Draft design transfer documentation for multiple production lines.
  • Analyze and design process workflows to improve efficiency and maximize production capacity.
  • Apply Lean Manufacturing Methodology and Six Sigma tools to drive process improvements.
  • Develop and implement manufacturing process development, implementation, and continuous improvement strategies to enhance yield, reduce cost, and operator dependency.
  • Represent Process Engineering in R&D and Project Team meetings and provide technical expertise and support.
  • Perform or manage process validations and troubleshoot production line issues.
  • Lead scaling up processes from development to full-scale manufacturing.
Requirements
  • Bachelor's degree in a scientific or engineering discipline.
  • Minimum 5 years of experience in medical device manufacturing, preferably with catheter experience.
  • Minimum 5 years of Process Engineering experience.
  • Working knowledge of mechanical design principles and FDA regulated medical device design controls.
  • Proficient in CAD software, preferably SolidWorks.
  • Statistical analysis of raw data and proficiency in Minitab are required.
  • Hands-on experience managing suppliers and/or contract manufacturers is a plus.
  • Familiarity with design control according to 21 CFR 820 or ISO 13485 is preferred.
Knowledge, Skills, and Abilities
  • Proficient in Risk Management according to ISO 14971.
  • Knowledge of ASME Y14.5 GD&T.
  • Excellent interpersonal, communication, and documentation skills.
  • Takes initiative and acts quickly to drive solutions.
  • Strong interpersonal, organizational, and communication skills.
  • A flexible team player with a positive results-oriented attitude.


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