Senior Manufacturing Engineer

2 days ago

Mountain View, California, United States Bruker Full time
About the Role:

The Operations team at Bruker is seeking a Senior Manufacturing Engineer to lead New Product Introduction (NPI) activities, develop and implement streamlined product manufacturing and test processes, and provide technical support to manufacturing teams. This role will involve collaborating with cross-functional teams to ensure product quality and supply chain readiness.

Responsibilities:
  • Drive NPI transfer from engineering to production for successful launches
  • Develop NPI product value chain (make vs buy) and supply chain strategy to ensure NPI quality and supply chain readiness
  • Represent Operations on Engineering, Product Marketing, and Program Management teams
  • Provide technical support to manufacturing teams to improve productivity, efficiency, quality, timely delivery, and reduction of costs
  • Manage release and maintenance of product assembly drawings, bill of materials, and component drawings per ISO-9001/FDA GMP design and document control environment
  • Develop effective assembly procedures, QA procedures, and process control documents
  • Establish manufacturing process flow diagrams and process validation procedures
  • Evaluate process capability and identify areas for improvement
  • Collect and analyze in-process data to determine areas for process improvement
  • Build quality into processes, including process flow and Failure Mode Effects analysis as well as gauge reproducibility and reliability
  • Troubleshoot customer RMAs
  • Promote a strong culture of Continuous Improvement philosophies
Qualifications:
  • BS/MS degree in Engineering (Mechanical, Industrial, Manufacturing, or related field)
  • 3+ years of manufacturing engineering experience in a Med device (preferred) or high-tech manufacturing environment with demonstrated leadership abilities
  • New Product Introduction (NPI) experience including developing, manufacturing, and releasing product and ramp-up to full-scale production
  • Excellent hands-on technical skills with miniature or precision mechanical, electro-mechanical, and opto-mechanical assemblies
  • Mechanical design aptitude with standard 3D CAD tools (e.g., SolidWorks)
  • Knowledge of optical design with some experience with optical CAD tools (e.g., Zemax)
  • Thorough and detail-oriented with strong troubleshooting skills and the ability to think at a systems level
  • Experience developing documentation and procedures for manufacturing and service teams and maintaining accurate and comprehensive Design History Records and engineering/manufacturing documentation
  • Strong team player proficient working in an interdisciplinary environment managing multiple projects/deliverables
  • Medical device industry experience with ISO/GMP's preferred
  • Knowledge of component manufacturing processes (including machining, injection molding, wire EDM, cabling, etc.)
  • Strong analytical, written, and verbal communication skills

Bruker is an equal-opportunity employer and prohibits discrimination and harassment of any kind. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

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