Process Development Engineer

Process Engineer

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference.

We are looking for driven, talented Process Engineers to join the Manufacturing Technology & Transfer team within Global Operations. This position is an integral part of our Consumables Development and Manufacturing teams and is tasked with developing and deploying consumables manufacturing and assembly processes for internal and external production environments. The individual will provide technical leadership to new product introduction, partner closely with development teams, Quality, Production, Supply Chain, and other engineering groups to develop, transfer and sustain manufacturing processes.

Responsibilities:

• Participate in consumable product development, manufacturing process development, process and product improvements, and other activities in the making of consumable products to sequence genomes
• Represent Operations needs on development teams for effective transfer of products into manufacturing
• Define technical requirements for manufacturing processes and new production equipment
• Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment
• Design, develop and source production equipment from vendors and OEM's, work cross functionally with EHS and Facilities to establish safe production processes to enable manufacturing of consumable products
• Troubleshoot new product and manufacturing process issues related to yield, quality and throughput
• Develop understanding of CPM (critical parameter management), construct and execute controlled experiments and including DOE's to optimize processes, address yield and quality issues and drive implementation of solutions into a production environment to meet project goals
• Analyze process test results, issue reports and make technical recommendations to improve product and process quality
• Utilize expertise in 6-sigma, DFSS, 8D, DMAIC to solve issues that arise during product and process development phases of new product introductions
• Work cross functionally with Product Development, Supply Chain, Manufacturing, Quality teams to enable operations for both launch and high-volume manufacturing
• Ensure successful transfer of knowledge into manufacturing and the sustaining support teams

Requirements:

• Experience with consumable design and fabrication, assembly process development, working with global contract manufacturing houses
• Ability to read and interpret mechanical engineering drawings, GD&T experience is a plus
• Ability to evaluate First Article Inspection, propose improvements to enhance quality and work with external vendors to implement changes
• Experience with product development processes, design transfer and process and equipment validation
• Experience with Statistics, Statistical Process Control and DOE techniques is a plus, high level problem solving, and reasoning skills required
• Experience with cGMP and 21 CFR part 11 and supporting manufacturing in an FDA regulated environment is preferred
• Effective communication skills both verbal and written, analytical and organizational skills to manage competing project priorities
• Experience with high volume production in a high tech, high volume consumables industry is a plus
• High level computer skills are required. Intermediate level programming knowledge is a plus
• Experience with product development processes and project management is a plus
• Demonstrated ability to accomplish goals while working across departments is required

Education and Experience:

• B.S./M.S./PhD in Mechanical Engineering, Chemical Engineering, Material Science, or Bioengineering, with 2-4 years of relevant experience in product design, process development, scale-up, process improvement, quality engineering