Process Development Engineer at Illumina

San Diego, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Genomics, Life Sciences, ManufacturingIndustries

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

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

Skills

Process Development

Manufacturing Processes

GMP

New Product Introduction

Production Equipment Design

Technical Leadership

Cross-Functional Collaboration

Process Transfer

Assembly Processes

Vendor Sourcing

Illumina

Supports genomics startups through funding and resources

About Illumina

Illumina focuses on fostering innovation in the genomics industry by supporting startups through its Illumina Accelerator program. This program helps entrepreneurs create, launch, and grow genomics-focused companies by providing funding and resources. The accelerator operates in two main locations: the San Francisco Bay Area and Cambridge, UK. Illumina Accelerator has successfully invested in 68 genomics startups, which have collectively raised over $1 billion in venture capital. What sets Illumina apart from its competitors is its strong partnership with leading venture capital investors and its dedicated focus on the genomics sector. The goal of Illumina is to build a thriving ecosystem for genomics innovation, enabling new companies to emerge and advance the field.

San Diego, CaliforniaHeadquarters

1998Year Founded

$27.2MTotal Funding

IPOCompany Stage

Venture Capital, BiotechnologyIndustries

5,001-10,000Employees

Risks

Over-reliance on NVIDIA's AI technology may limit flexibility in AI solution adoption.

Standardizing proteomics data across platforms could challenge Illumina's data reliability.

Single-flow-cell NovaSeq X System might cannibalize sales of higher-end models.

Differentiation

Illumina leads in genomic sequencing with advanced AI integration and multiomic data analysis.

The company offers innovative array-based solutions for DNA, RNA, and protein analysis.

Illumina's global expansion includes a new Global Capability Center in Bengaluru.

Upsides

Collaboration with NVIDIA enhances drug discovery and clinical development through AI integration.

Pilot proteomics program with UK Biobank aims to generate crucial reference datasets.

Single-cell sequencing kits make high-throughput sequencing accessible to smaller labs.

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