The selected candidate will report into the Illumina Life Cycle Management team and provide technical support to the Operations organization in the areas of (micro) fluidic architecture, trouble-shooting, design for reliability and manufacturability and manufacturing transfer of new product. The engineer needs to be a self-starter, analytically oriented, and able to provide technical leadership in the evaluation and implementation of new technologies.
Skills & Experience
• BSME + 15 years experience required MSME/Ph.D + 10 years experience preferred.
• Design and manufacturing transfer of a high-volume microfluidic product required.
• Proficiency in basic fluidics analysis is required (CFD, FEA).
o Experience in CFD analysis for design optimization a plus (e.g. CFD-ACE, Comsol etc.)
• Experience with experiment design and execution, including the design of experiments and root cause analysis.
• Ability to work independently and collaboratively across disciplines is required.
• Demonstrated technical leadership in managing NPI projects.
• Hands on familiarity with valves, pumps and microfluidics in the Life Sciences area.
• Comfortable with complexity and ambiguity with an ability to see the big picture. Ability to collect, prepare, and present relevant information to influence decision-making within the organization.
• Ability to drive the accuracy, completeness, and timeliness of required specifications and documentation for electro-mechanical assemblies and OEM systems.
• Demonstrated use and understanding of Product Data Management Systems, Change Control processes and New Product Introduction.
• Knowledge and skills in process and product validation of a variety of equipment and processes used to build medical products.
• Requires strong analytical, written and verbal communication skills as well as the ability to interface with all departments and manage multiple projects and deliverables.
• Experience developing manufacturing work instructions, test methodologies and process flow procedures for hardware.
• Knowledge of 3D CAD tools such as SolidWorks.
• Must have good computer software skills with word processing, database management and spreadsheets.
• Familiarity with Agile PLM is a plus.
• Medical product industry experience with ISO 13485 and GMP’s a plus.
• Demonstrated efficiency in providing engineering support on multiple concurrent projects.
• Provide support to Corporate and Manufacturing Lean Manufacturing and Quality System implementation programs.
Illumina is an Equal Opportunity Employer