Senior Software V&V Engineer

2 hours, 59 minutes ago
Full-time
Senior
Quality Assurance and Testing
Natera

Natera

Natera specializes in cell-free DNA testing, providing advanced genetic testing services for oncology, women's health, and organ health to help families diagnose and manage genetic diseases.

Pharmaceuticals
1K-5K
Founded 2004

Description

  • Own verification and validation activities across the software portfolio.
  • 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 selected laboratory instruments.
  • Design and execute verification tests for NGS bioinformatics pipelines and algorithms.
  • Develop and maintain test templates, protocols, test cases, and traceability matrices.
  • Review executed test cases, assess variances, and partner with QA to resolve findings.
  • Approve test reports and ensure documentation complies with design controls.
  • Manage the cadence, prioritization, and execution of V&V work across concurrent programs.
  • Travel regularly to the Boulder, CO lab to support testing, integration, and collaboration.

Requirements

  • 4+ years conducting and overseeing software verification and validation for regulated medical device software (510(k) and/or PMA).
  • 3+ years designing and executing verification tests for NGS bioinformatics pipelines.
  • 2+ years of testing experience in cloud environments (AWS or GCP).
  • Direct working knowledge of ISO 13485 and IEC 62304 design controls.
  • 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 is required.
  • Excellent written and verbal communication skills for clear, compliant documentation.
  • Testing experience with pipeline orchestration tools such as Nextflow (preferred).
  • Hands-on exposure to clinical laboratory workflows, especially CAP/CLIA environments (preferred).
  • Familiarity with LIMS/LIS platforms in a regulated diagnostic context (preferred).
  • Experience contributing to or preparing FDA submissions such as 510(k) or PMA from a V&V documentation standpoint (preferred).

Benefits

  • Comprehensive medical, dental, vision, life, and disability coverage for eligible employees and dependents.
  • Free testing for employees and their immediate families.
  • Fertility care benefits.
  • Pregnancy and baby bonding leave.
  • 401(k) benefits.
  • Commuter benefits.
  • Generous employee referral program.

Interested in this position?

Apply directly on the company website

Apply Now

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