2 days ago

Senior Software V&V Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 10 hours agoStatus: Live

Job Summary

Own verification and validation across a regulated software portfolio that powers MRD results, from bioinformatics pipelines to lab automation and LIMS/LIS integrations. Collaborate with bioinformaticians, software engineers, and clinical lab teams to design and execute IEC 62304/ISO 13485-aligned test cases, maintain audit-ready protocols, and ensure complete traceability. Travel regularly to support lab testing, integration, and cross-functional delivery.

Location: United States, Boulder

Workplace: Remote

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Own verification and validation activities across the software portfolio, partnering with bioinformaticians, software engineers, and clinical lab teams.
•Align software testing processes with IEC 62304 and ISO 13485 design control requirements.
•Oversee V&V for pipeline software, lab automation methods, reagent QC software, LIMS/LIS tools, and select laboratory instruments.
•Design and execute software verification tests for NGS bioinformatics pipelines, including end-to-end workflows and individual algorithms.
•Maintain V&V traceability and audit-ready documentation, including approving test reports and managing V&V cadence and prioritization across programs, with regular travel to the Boulder lab.

Travel: Medium travel

Pay and Benefits

Perks:Health InsuranceDentalVisionLife InsuranceDisability Insurance401kRemote WorkPaid LeaveFertility CareCommuter Benefits

Key Requirements

•4+ years conducting and overseeing software verification and validation for regulated medical device software (510(k) and/or PMA pathways).
•3+ years designing and executing verification tests for NGS bioinformatics pipelines, including NGS analysis workflows and algorithm testing.
•2+ years of testing experience in cloud environments (AWS or GCP).
•Direct working knowledge of ISO 13485 and IEC 62304 design controls (applied, not just familiarity).
•Cross-functional experience with bioinformaticians, software engineers, and clinical laboratory teams; plus prior bioinformatics, computational biology, or biology-related work.

Experience:Molecular diagnosticsBioinformaticsNGSRegulated medical devicesCloudClinical laboratory

Skills:Written communicationVerbal communicationDocumentationCross-functional collaborationAudit readiness

Languages:English

Tech Stack:IEC 62304ISO 13485AWSGCPNextflowNGSLIMSLIS510(k)PMACAP/CLIA

Company Brief

Natera

Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.

Industry: Diagnostics

Company Size: Enterprise (1,001+ employees)

Revenue: USD 500M to 1B

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: San Carlos, United States

Founded: 2004

Website LinkedIn

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Natera

2 days ago

Senior Software V&V Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 10 hours agoStatus: Live

Job Summary

Location: United States, Boulder

Workplace: Remote

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Own verification and validation activities across the software portfolio, partnering with bioinformaticians, software engineers, and clinical lab teams.
•Align software testing processes with IEC 62304 and ISO 13485 design control requirements.
•Oversee V&V for pipeline software, lab automation methods, reagent QC software, LIMS/LIS tools, and select laboratory instruments.
•Design and execute software verification tests for NGS bioinformatics pipelines, including end-to-end workflows and individual algorithms.
•Maintain V&V traceability and audit-ready documentation, including approving test reports and managing V&V cadence and prioritization across programs, with regular travel to the Boulder lab.

Travel: Medium travel

Pay and Benefits

Perks:Health InsuranceDentalVisionLife InsuranceDisability Insurance401kRemote WorkPaid LeaveFertility CareCommuter Benefits

Key Requirements

•4+ years conducting and overseeing software verification and validation for regulated medical device software (510(k) and/or PMA pathways).
•3+ years designing and executing verification tests for NGS bioinformatics pipelines, including NGS analysis workflows and algorithm testing.
•2+ years of testing experience in cloud environments (AWS or GCP).
•Direct working knowledge of ISO 13485 and IEC 62304 design controls (applied, not just familiarity).
•Cross-functional experience with bioinformaticians, software engineers, and clinical laboratory teams; plus prior bioinformatics, computational biology, or biology-related work.

Experience:Molecular diagnosticsBioinformaticsNGSRegulated medical devicesCloudClinical laboratory

Skills:Written communicationVerbal communicationDocumentationCross-functional collaborationAudit readiness

Languages:English

Tech Stack:IEC 62304ISO 13485AWSGCPNextflowNGSLIMSLIS510(k)PMACAP/CLIA

Company Brief

Natera

Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.

Industry: Diagnostics

Company Size: Enterprise (1,001+ employees)

Revenue: USD 500M to 1B

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: San Carlos, United States

Founded: 2004

Website LinkedIn