Senior Product Engineer

Illumina•San Diego, CA

About The Position

We are looking for a technical expert for our Consumables Manufacturing Technology and Transfer (MTT) group. The MTT 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 accountable for representing MTT on a single or multiple teams focused on development and transfer to Operations of RUO and IVD library preparation, sequencing, and micro-array based assay reagents and consumables. In addition, this person will perform Operations assessment and support of new corporate and business development partnership opportunities such as co-development, co-marketing, divestitures, acquisitions, supply-outs, OEM/Distribution, and Clinical Diagnostics Pharma partnerships.

Requirements

Demonstrated ability to problem solve, provide supporting evidence, propose solutions, make decisions, and build consensus in a multi-disciplinary, cross-departmental environment.
Ability to communicate effectively and build strong relationships across multiple departments.
Ability to work in fast-paced environment; easily adaptable to changing priorities.
Knowledgeable of ISO 13485, ISO 14971, 21 CFR 820 / 11
Experience with statistics, Statistical Process Control and DOE techniques.
Knowledge of Molecular Biology basics and DNA sequencing preferred.
Experience troubleshooting a variety of object-oriented programming languages (R, Camstar MES, VENUS)
B.S./M.S. in Chemical Engineering, Bioengineering, Biotechnical Engineering, Bioinformatics, Biological Sciences, Materials Science or Physical Chemistry or equivalent discipline.
5+ years of industry experience with an MS/BS, or 0+ years of experience with Ph.D.

Nice To Haves

Work experience with product development, project management, design change control programs is preferred.
Experience with high-tech consumables manufacturing, validated manufacturing systems, and process validation procedures is a plus.

Responsibilities

Accountable for the operation’s deliverables for new product introduction and operations partnership projects.
Establish manufacturing and QC process requirements to meet product specifications.
Ensure the projects meet the required design history deliverables as needed for clinical or RUO products.
Collaborate closely across all of Global Operations to present a unified voice to the product development teams.
With manager’s oversight, provide operational support and content for proposed business development deals.
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.
Present clear and concise written and oral communications to colleagues and supervisors, lead and participate in technical meetings, and provide recommendations based on results.
Author technical operations documents, such as plans/protocols, engineering reports, SOPs.
Release documents, bills of materials and device master record data into ERP system.