Engineer 2 - Process Development
IlluminaWhat if the work you did every day could impact the lives of people you know? Or all of humanity? 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. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Summary: We are seeking a hands-on Process Development Engineer II to join the Manufacturing Technology & Transfer (MTT) team. This role develops, characterizes, scales, transfers, and sustains manufacturing processes for new consumable products. The primary technical scope includes precision adhesive and epoxy bonding, laser drilling and laser dicing, die or component singulation, automated pick-and-place, wire bonding, and consumable cartridge assembly. The engineer will work cross-functionally with R&D, Manufacturing, Quality, Supply Chain, Equipment Engineering, Facilities, and EHS to establish capable, scalable, safe, and compliant processes from development through production ramp. Responsibilities: Own process development workstreams for new product introduction, from early feasibility and process definition through characterization, validation, transfer, and production ramp. Develop high-volume mechanical operations and assembly processes involving adhesive bonding, epoxy-based assembly, laser drilling, laser dicing, die or component singulation, automated pick-and-place, wire bonding, and consumable cartridge assembly. Translate product requirements and critical-to-quality characteristics into process requirements, control strategies, acceptance criteria, and manufacturing specifications using Critical Parameter Management principles. Plan, execute, and analyze controlled experiments, including design of experiments (DOE), to establish process windows, optimize performance, and improve yield, quality, reliability, and cycle time. Support the selection, development, qualification, and transfer of production equipment, tooling, fixtures, materials, automation, and inspection or metrology methods. Apply standard process-engineering tools, including process failure mode and effects analysis (PFMEA), control plans, statistical process control (SPC), Gage R&R, and process capability analysis (Cp, Cpk, Pp, and Ppk, as applicable). Perform structured root-cause analysis using methods such as 8D, fault-tree analysis, cause-and-effect analysis, and data-driven problem solving; implement and verify corrective actions. Generate clear technical documentation, including development plans, experiment protocols, technical reports, work instructions, process specifications, validation documentation, and manufacturing transfer packages. Drive product and process change control, and risk management, required for successful product launch and lifecycle support. Provide technical direction across project teams, identify technical and schedule risks, recommend mitigations, and communicate decisions and tradeoffs to stakeholders. Serve as a technical resource for critical process and product characteristics, supporting troubleshooting, supplier collaboration, production ramp, and sustained process performance. Requirements: Bachelor's degree in Mechanical engineering, Manufacturing Engineering, Materials Science, Electrical Engineering, Bioengineering, Biomedical Engineering, or related technical field. Two or more years of relevant industry experience in manufacturing process development, new product introduction, process characterization, production support, scale-up, manufacturing transfer, improvement, qualification, or validation. Hands-on experience developin…