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Illumina · 1 day ago

Senior Product Engineer

US - California - San Diego

Full-time

Onsite

Mid, Senior Level

$98K/yr - $148K/yr

5+ years exp

Illumina is a company focused on expanding access to genomic technology to promote health equity. They are seeking a Senior Product Engineer to be a technical expert in their Consumables Manufacturing Technology and Transfer group, responsible for new product introduction and improving quality and yield in high-volume production environments.

BiotechnologyGeneticsHealth CareMedical

No H1B

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

Qualification

ISO 13485Statistical Process ControlMolecular BiologyObject-oriented programmingProduct developmentProject managementProblem solvingEffective communicationAdaptability

Required

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)

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

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