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Lead Process Engineering Specialist

2 months ago

Carlsbad, United States Bolt Medical Full time

JOB OVERVIEW:

Bolt Medical is seeking an experienced Process Development Engineer to enhance our engineering team. In this role, you will be tasked with the design, enhancement, and refinement of manufacturing processes to achieve optimal production efficiency. Collaboration with cross-functional teams will be essential to facilitate a smooth transition from conceptual design to full-scale production.

KEY RESPONSIBILITIES:

  • Assess and refine existing manufacturing methodologies.
  • Direct process development and enhancement initiatives.
  • Act as a liaison between Research & Development and Manufacturing departments.
  • Examine operational workflows to boost productivity.
  • Implement Lean Manufacturing principles and Six Sigma practices.
  • Oversee process validation and resolve production challenges.
  • Revise manufacturing documentation and Standard Operating Procedures (SOPs).

QUALIFICATIONS:

  • Bachelor's degree in a relevant scientific or engineering field.
  • A minimum of 5 years' experience within the medical device sector.
  • Familiarity with mechanical design concepts and regulatory standards.
  • Expertise in CAD tools, especially SolidWorks.
  • Experience with statistical analysis software, such as Minitab.
  • Excellent communication and interpersonal skills.

SKILLS AND COMPETENCIES:

  • Expertise in Risk Management in accordance with ISO standards.
  • Understanding of engineering standards, including ASME Y14.5 GD&T.
  • Proactive and results-oriented approach.
  • Ability to thrive in a collaborative team environment.