Senior Automation Development Engineer

Danaher   •  

Sunnyvale, CA

Industry: Manufacturing & Automotive

  •  

8 - 10 years

Posted 31 days ago


Description


  • Job Description
  • The successful candidate will use their industry experience to design and develop assembly processes for medical device manufacturing.
  • They will evaluate current capabilities, available technology in the industry, and product requirements to develop new and improve current assembly methods and processes, drive equipment design in a large-scale environment.
  • Use statistical analysis to develop assembly processes and drive continuous improvement in collaboration with a diverse and highly talented engineering team.
  • This is a hands-on position involving concept development, process characterization, and validation (transfer to production); must be able to interface well with other engineers, scientists and operations personnel.
  • Experience with automated assembly is required.
  • There are no direct reports to this position.
  • Senior Automation Development Engineer
  • The successful candidate will use their industry experience to design and develop assembly processes for medical device manufacturing.
  • They will evaluate current capabilities, available technology in the industry, and product requirements to develop new and improve current assembly methods and processes, drive equipment design in a large-scale environment.
  • Use statistical analysis to develop assembly processes and drive continuous improvement in collaboration with a diverse and highly talented engineering team.
  • This is a hands-on position involving concept development, process characterization, and validation (transfer to production); must be able to interface well with other engineers, scientists and operations personnel.
  • Experience with automated assembly is required.
  • There are no direct reports to this position.
  • Responsibilities:
  • Design and perform process characterization studies & DOE's to develop new and/or improve existing assembly processes.
  • Design, test, and validate new automation processes and/or designs in collaboration with a diverse functional engineering team.
  • Write Verification/Validation protocols (I/OQ, PQ) and related technical reports to support the transfer of processes into Production.
  • Partner with cross functional teams to evaluate design and processes at concept phase and define manufacturing processes.
  • Develop new and/or improved processes for parts and assemblies through the application of theoretical and practical engineering.
  • Assist in failure investigations and root cause analyses as they relate to process performance.
  • Use 3D CAD modeling, CAE, statistical analysis, and hands-on bench or line testing to characterize attributes, process performance, and assembly characteristics.TRAINING RESPONSIBILITIES:
  • Complete all assigned and required training satisfactorily and on time



Qualifications


Minimum Requirements:

  • Bachelor's degree with 8+ years of related work experience OR Master's degree in field with 6+ years of related work experience OR Doctoral degree in field with 3+ years of work experience.
  • BS in Mechanical, Plastics, or Manufacturing Engineering or equivalent combination of education and experience to perform at this level.
  • A minimum of 5+ years overall related engineering experience within medical device or a regulated industry.
  • Working knowledge of GMP, ISO, and FDA rules and regulatory requirements. Automotive, aerospace, or other regulated industry experience may be considered.
  • Proven experience with DOE's, root cause analysis, process engineering, failure investigations and automated assembly equipment.
  • Experience in process development, acceptance testing and qualification of equipment.
  • Excellent communication skills. Must be proficient in document preparation and editing, including detailed test planning and report writing. Excellent verbal and written communication skills.
  • Proficiency with SolidWorks, MiniTab, and Microsoft Office applications.
  • Experience with creating BOMs, product specifications, and engineering drawings interpretation (GD&T).Preferred Requirements:

  • Project management experience would be a plus.
  • Quality Management System experience preferred.