Process Development Manager

3 days ago


Carlsbad, United States Bolt Medical Full time
Job Summary

Bolt Medical is seeking a highly skilled Process Development Manager to lead our therapeutic device development program. As a key member of our team, you will be responsible for supervising and providing technical leadership to process development engineering employees.

Key Responsibilities
  • Process Development: Create and implement manufacturing processes for Bolt Medical's new and current catheter devices.
  • Process Optimization: Identify new catheter medical device equipment and processes to optimize process throughput and process reliability.
  • Validation and Verification: Perform characterization, Design of Experiments (DoE), and write/perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
  • Documentation and Training: Create manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMR, and DHF documents. Train and provide direction to direct reports and manufacturing personnel.
  • Team Leadership: Lead a team of engineers and technicians on business activities for the process development team.
  • Innovation and Design: Innovate, design, and develop processes, procedures, tooling, and/or automation.
  • Machine Shop Management: Manage machine shop engineers/technicians.
  • Functional Excellence: Drive functional excellence initiatives for product/process and technical development.
  • Department Management: Develop department budget, schedules/forecast, and resources.
  • Production Builds: Manage production builds for development projects and optimization to meet business needs.
Requirements
  • Education: Bachelor's Degree in Engineering, preferably mechanical or biomedical.
  • Experience: 12+ years of medical device experience in a process/manufacturing engineering role. Minimum of 8 year's experience working in catheter manufacturing environment.
  • Skills and Abilities: Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements. Excellent verbal and written communication skills. Ability to organize, record, and implement procedures. Experience with CAD (Solid Works) to create and design fixtures and equipment. Understanding of six sigma principles (certificate desired) and statistical software such as Minitab.


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