Senior Software V&V Engineer

Natera

. Own verification and validation activities across Foresight's software portfolio .

Posted 11/5/2026full-timeBoulder • Colorado • United StatesSenior💰 $108,700 - $140,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in software verification and validation for regulated medical devices, with a strong focus on NGS bioinformatics pipelines and compliance with IEC 62304 and ISO 13485 standards. Proficient in developing test protocols and collaborating cross-functionally to ensure documentation and testing integrity.

Highest-signal resume keywords

Software Verification And ValidationNGS Bioinformatics Pipeline TestingISO 13485 ComplianceIEC 62304 Design ControlsCloud Testing Experience (AWS or GCP)

ATS Keywords

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Hard Skills

Verification TestingValidation ActivitiesTest Protocol DevelopmentTest Case DesignTraceability Matrix ManagementRegulatory Submission PreparationBioinformatics AnalysisLaboratory Instrument TestingPipeline Orchestration ToolsClinical Laboratory Workflows

Soft Skills

Excellent Communication SkillsCross-Functional Collaboration

Tools & Technologies

LIMS/LIS PlatformsNextflowAWSGCP

Industry Keywords

Regulated Medical Device Software510(k) PathwayPMA PathwayCAP/CLIA EnvironmentBioinformaticsComputational Biology

Tech Stack

Tools & technologies

AWSCloudGoogle Cloud Platform

About the role

Key responsibilities & impact

Own verification and validation activities across Foresight's software portfolio
Align software testing processes with IEC 62304 and ISO 13485 design control requirements
Oversee V&V activities 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 NGS algorithms
Develop and maintain test templates, test protocols, and IEC 62304-aligned test cases
Review executed test cases, assess variances, and collaborate with Quality Assurance to resolve and document findings
Approve test reports and ensure documentation compliance under design controls
Establish and maintain V&V traceability across device software, lab automation tools, and lab instruments
Oversee software traceability matrices across device software components
Manage the cadence, prioritization, and execution of V&V activities across concurrent programs
Travel regularly to the Foresight lab in Boulder, CO for testing, lab integration work, and cross-functional collaboration

Requirements

What you’ll need

4+ years conducting and overseeing software verification and validation activities for regulated medical device software (510(k) and/or PMA pathways)
3+ years designing and executing verification tests specifically for NGS bioinformatics pipelines, including NGS analysis workflows and individual algorithm testing
2+ years of testing experience in cloud environments (AWS or GCP)
Direct working knowledge of ISO 13485 and IEC 62304 design controls, with applied experience
Prior experience working cross-functionally with bioinformaticians, software engineers, and clinical laboratory teams
Prior work experience in bioinformatics, computational biology, or a biology-related field
Excellent written and verbal communication skills, with the ability to translate complex technical findings into clear, compliant documentation
Testing experience with pipeline orchestration tools such as Nextflow (preferred)
Hands-on exposure to clinical laboratory workflows and CAP/CLIA environment experience (preferred)
Familiarity with LIMS/LIS platforms in a regulated diagnostic context (preferred)
Experience contributing to or preparing for FDA submissions (510(k) or PMA) from a V&V documentation standpoint (preferred)

Benefits

Comp & perks

Annual performance incentive bonus
Long-term equity awards
Comprehensive health benefits (medical, dental, vision)
401(k) with company match
Generous paid time off and company holidays
Additional wellness and work-life benefits
Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
Free testing for Natera employees and their immediate families
Fertility care benefits
Pregnancy and baby bonding leave
Commuter benefits
Employee referral program