We are looking for a technical expert for our Consumables Process Development and Transfer (cPDT) group. The cPDT group works as an integral part of our Consumables Manufacturing process and is tasked with new product introduction and increasing quality and yield within our high-volume production environments.
This individual will be primarily accountable for representing cPDT on a single or multiple Teams focused development and transfer to Operations of RUO and IVD sequencing and micro-array assays. The role ensured best-in-class product quality and optimized cost of goods through proactive integration of risk-based design requirements, performance testing controls, and manufacturing strategies into the product development process. Additionally, this person will lead as appropriate enhancement of on-market products, and enhance/develop risk-based design and transfer processes within cPDT.
This position for the Operation’s team will enable the development of Illumina’s core technologies and applications in one of the most technically innovative spaces in industry. The ideal candidate will have experience in representing Operations on cross functional project teams to ensure and enable the risk-based transfer, launch, and on market support of complex clinical diagnostics. The technical areas of expertise are broad including assay design, manufacturing process development, and QC testing.
· Accountable for the operation’s deliverables for new product introduction projects, ensuring best-in-class product quality and optimized cost of goods through proactive integration of risk-based design requirements,
performance testing controls, and manufacturing strategies into the product development process.
· Technical leader for ensuring risk-based product design, specifications, manufacturing process design, and post-launch metrics to create effective and reliable products
· Ensure the projects meet the required design history deliverables as needed for clinical and RUO products
· Collaborate closely across all of Global Operations to ensure a unified voice to the NPI core teams
· With manager’s oversight, provide operational support and content for Regulatory submissions and product instructions for use.
· Assists with the resolution of non-conformances and complaints generated within the early launch period, and ensures lessons learned are incorporated into future product development programs
· Experience in transferring clinical diagnostic products from Development to Operations in a highly cross-functional environment preferred.
· Experience with manufacturing process development, production, and QC testing of clinical diagnostics is preferred.
· Experience with application of ISO13485, QSR, GMP/GLP, and FMEA/PFMEAs to product design, testing, and manufacturing is required.
· System-level experience in integrating across multiple disciplines and new technologies.
· Experience in leading resolution of multi-disciplinary, cross-departmental technical problems.
· Demonstrated ability in collaborating with and mentoring technical staff.
· Experience in high-volume production in a high-tech consumables industry is a plus.
· Experience with statistics, Statistical Process Control and DOE techniques is preferred.
· Problem solving, and reasoning skills required.
· Excellent interdepartmental communication, influence and documentation skills are required.
· Demonstrated ability to accomplish goals while working across departments is required
· Experience with manufacturing and testing process validation procedures is a plus.
BSc/MS: 8+ years of experience
PhD: 3+ years of experience
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