Sr. Software Design Quality Engineer

England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Genomic Technology, Biotechnology, HealthcareIndustries

Requirements

Candidates must possess a B.S./M.S. in a relevant engineering field such as biomedical, computer science, software, or electrical, or an equivalent scientific degree. A significant amount of progressive Quality Engineering experience in the medical device industry, with hands-on support for software development, is required. A strong understanding of international medical device/IVDR regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, and ISO14971, is essential, along with a solid grasp of software development best practices.

Responsibilities

The Senior Software Design Quality Engineer will provide technical and strategic feedback for IVDR, RUO, and digital health software in accordance with regulations, standards, and business needs. This role involves leading the development and maintenance of the Risk Management File, including plans, hazard analysis, dFMEAs, pFMEAs, and reports. The engineer will provide Quality Engineering input, review, and approval for the Design History File and associated documentation, overseeing software product development plans, design inputs/outputs, verification, and validation. Responsibilities also include quality oversight and approval of test planning, protocols, and reports, serving as the Subject Matter Expert for software quality, and collaborating with teams on code reviews, software security analysis, defect triage, and sBOM creation. The role requires participation in design reviews, fostering positive relationships with stakeholders, and supporting other Quality System areas as needed.

Skills

IVDR compliance

RUO software compliance

Risk management

Software quality processes

Cross-functional collaboration

Software security

Risk mitigation

Product lifecycle management

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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