Engineer 2, Product Lifecycle

  • Illumina
  • US - Bay Area - Hayward
  • Aug 04, 2020
Full time Biotech Science

Job Description

The Engineer 2 will be responsible for engineering development, new product introduction, & sustaining activities in manufacturing of DNA sequencing instruments. The role requires a background in an engineering discipline in mechanical, chemical, bioengineering, electrical, or relevant instrumentation work with a science background in biology, chemistry, or related field. The position requires system and subassembly troubleshooting, problem solving, testing and support with development, manufacturing operators & contract manufacturers. As needed, the engineer will communicate trending issues to a larger cross-functional team (Supply Chain, MFG, Quality, R&D, Regulatory & Process Engineering) to state the defined problem statement and provide updates on root cause analysis/proposed solution.  This systems engineer will also help support and drive process/design improvement projects, cost-savings initiatives & resolutions to line-down situations. This role will provide the necessary support to ensure GMP compliance and other regulatory requirements are maintained within production. 

 

Responsibilities:

  • Troubleshoot system level issues in the areas of mechanical, fluidics, optical, consumables, software, and electrical subsystems
  • Support new product introduction into manufacturing (topics range from mechanical, fluidics or system-level testing/ DNA sequencing analysis)
  • Creates and conducts engineering verification test plans to qualify components, processes, and systems
  • Deliver technical presentations to upper management, peers, and stakeholders
  • Participate in 6 Sigma problem solving projects to reduce Non Conformances on instruments
  • Interacts with Suppliers and Contract Manufacturers to support and/or improve outsourcing processes
  • Create and implement ECO changes to product and manufacturing processes
  • Responsible for evaluating manufacturing Non Conformances
  • Work with cross functional teams (Quality, Manufacturing, Development, Regulatory, Supply Chain) to achieve Instrument Manufacturing Operation Goals while maintaining good Compliance status

 

Required Skills:

  • Candidate must be organized, a self-starter, highly motivated individual capable of multi-tasking
  • Understanding of GDP, GMP and Quality process controls
  • Ability to analyzes data, and effectively report problems through written and/or graphical formats
  • Ability to work in a highly collaborative and fast-paced environment
  • Excellent cross functional communication skills
  • Hands-on experience in troubleshooting instrument issues and root cause analysis (Six Sigma preferred)
  • Proficient in MS Office (Word, Excel, PowerPoint, VISIO)
  • Project management

 

Preferred Skills:

  • Strong understanding of mechanical engineering design/ tolerance analysis
  • Experience with troubleshooting fluidics issues in a complex instrument/device
  • Demonstrated use and understanding of change management process (SAP preferred)
  • Program language experience is not required, but a plus (SQL, C#, VBA for Excel, R, Python, Matlab, LabView)
  • Understanding of Genomics Technology information
  • Experience with FDA regulated medical device product development preferred
  • Technical project management & leadership

    Education:     

    BS/MS in Engineering: Mechanical, Chemical, Bioengineering, Electrical, or relevant instrumentation work with a Science background in Biology, Chemistry or related field

    Minimum of 2 years experience or equivalent in instrument manufacturing operations or product development