Design Quality Engineer 2 at Illumina

San Diego, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Medical DevicesIndustries

Requirements

Bachelor's Degree in Engineering and/or Science (preferred)
Master's Degree (advanced degree without experience or equivalent work experience)
PhD (advanced degree without experience or equivalent work experience)
2-5 years of related experience
2-5 years experience working within FDA/ISO regulated industry
Quality Certification (e.g. CQE) (preferred, upon hire)
Technical expertise in areas such as Assay Development, Bioinformatics, MFG Quality Engineering, Clinical Trials, Instrument Development (with focus on CMOS and MEMS) (preferred)
Knowledge of quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, trend analysis) (preferred)
Knowledge of FDA regulatory environment (CFR 820), 501k, ISO 14971, ISO 13485, and IVDR (preferred)
Team oriented with excellent communication skills
Excellent cross-functional collaboration
Detailed oriented, well organized, able to work independently and in teams
Adaptable to fast-paced, dynamic work environment with shifting demands

Responsibilities

Provide Quality oversight to ensure Illumina’s products and processes are safe, effective, and meet customer performance needs throughout the product lifecycles
Provide support for project planning, requirements/specifications development, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors
Ensure products meet appropriate regulatory requirements (e.g. FDA, IVDR, ISO) in compliance with the quality management systems
Lead product risk management activities
Audit the quality and completeness of product Design History Files and/or Device Master Record
Facilitate participation in the technical discussions and risk-based decision making utilizing knowledge of applicable technology
Support issue resolution using a risk-based approach
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
Utilize quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis)
Define and/or create processes to align with quality standards and business practices

Skills

Design Control

FDA 21 CFR 820

ISO 13485

ISO 14971

IVDR

Risk Management

Design Verification

Design Validation

Process Validation

Human Factors

Quality Management Systems

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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