Senior Manufacturing Systems Engineer

Senior Manufacturing Systems Engineer (Direct Hire)

San Francisco Bay AreaCA

Job Requisition: 6397

Description for Sr. Manufacturing Systems Engineer:
As an MES Project Manager you will be called upon to lead the Manufacturing and Quality engineering groups through the implementation of MES systems. You will provide robust solutions aimed at continuously improving existing systems and introducing new products onto the MES platform.  While working in the Manufacturing Engineering group, you will be collaborating cross-functionally with engineering groups across the company, as well as with Production and IT

Responsibilities for Sr. Systems Manufacturing Engineer: 
  • Discover and solve complex problems and implement innovative solutions
  • Be the liaison between manufacturing, production, IT, and other groups across the business for system improvement projects with your deep understanding of software processes
  • Use your creativity to oversee projects to completion
  • Execute detailed root cause analysis and drive execution of vetted solutions
  • Communicate and explain problems and solutions cross-functionally and inter-departmentally
  • Present independent recommendations for project approach, scope, and tactics
  • Create and maintain product and process documentation, including within the company’QMS
  • Monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield, usability, and ease of platform adoption
  • Author protocols to execute tests and write reports and make conclusions and/or recommendations based on test results
  • Plan, schedule, conduct, and coordinate detailed phases of cross-functional engineering work as part of a project or as a total project
  • Develop, characterize, and optimize processes using engineering knowledge and experience
  • Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans
  • Comply with quality system regulations, standards and procedures
Requirements for Sr. Systems Manufacturing Engineer:
  • BS degree in engineering or related life science
  • Strong knowledge of ISO 13486 Quality Management System (QMS) and experience with QMS software such as MasterControl
  • Experience working with Camstar Manufacturing Execution System (MES)
  • 3+ years of experience in medical device industry
  • A passion for tackling and solving technical problems
  • Proven ability to thrive in a fast-paced work environment 
  • The ability to communicate complex issues in a clear, compelling manner, both orally and in writing to technical and non-technical stakeholders
  • Strong project management skill set
  • Proven understanding of quality, operational, and financial systems
Desired Skills for Sr. Manufacturing Systems Engineer:
  • Knowledge of FDA regulations, lean manufacturing, and/or materials and manufacturing processes

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