19d 7h ago
Senior Software V&V Engineer
Natera·Molecular Diagnostics
📡Remote In-Country
|United States of AmericaSenior Software V&V Engineer
Natera | Molecular Diagnostics
2 weeks agoRemote In-Country
Full Time
United States of America
Position:
Senior Software V&V Engineer
Company:
Foresight Diagnostics (part of Natera)
Location:
United States, Remote
Employment type:
Not specified
Work Arrangement:
Remote with regular travel to Boulder, Colorado
Short Summary:
Foresight Diagnostics is seeking a Senior Software V&V Engineer to ensure the highest standards of verification and validation for software that impacts MRD results. The role requires deep understanding of bioinformatics pipelines and regulatory compliance.
Responsibilities:
- Own verification and validation activities across Foresight's software portfolio.
- Align software testing processes with IEC 62304 and ISO 13485 requirements.
- Oversee V&V activities for pipeline software, lab automation methods, and more.
- Design and execute software verification tests for NGS bioinformatics pipelines.
- Develop and maintain test templates, protocols, and IEC 62304-aligned test cases.
- Review executed test cases and collaborate with Quality Assurance to resolve findings.
- Approve test reports and ensure documentation compliance.
- Establish and maintain V&V traceability across software and lab instruments.
- Manage cadence and prioritization of V&V activities across programs.
- Travel to the Foresight lab in Boulder, CO for testing and collaboration.
Requirement:
- 4+ years in software verification and validation for regulated medical device software.
- 3+ years designing and executing verification tests for NGS bioinformatics pipelines.
- 2+ years of testing experience in cloud environments (AWS or GCP).
- Direct knowledge of ISO 13485 and IEC 62304 design controls.
- Experience working with bioinformaticians, software engineers, and clinical lab teams.
- Background in bioinformatics, computational biology, or a related field.
- Excellent communication skills for technical documentation.
Benefits:
- Comprehensive medical, dental, vision, life, and disability plans.
- Free testing for employees and their families, fertility care benefits.
- Pregnancy and baby bonding leave, 401k benefits, commuter benefits, and more.
Senior Software V&V Engineer
Company:
Foresight Diagnostics (part of Natera)
Location:
United States, Remote
Employment type:
Not specified
Work Arrangement:
Remote with regular travel to Boulder, Colorado
Short Summary:
Foresight Diagnostics is seeking a Senior Software V&V Engineer to ensure the highest standards of verification and validation for software that impacts MRD results. The role requires deep understanding of bioinformatics pipelines and regulatory compliance.
Responsibilities:
- Own verification and validation activities across Foresight's software portfolio.
- Align software testing processes with IEC 62304 and ISO 13485 requirements.
- Oversee V&V activities for pipeline software, lab automation methods, and more.
- Design and execute software verification tests for NGS bioinformatics pipelines.
- Develop and maintain test templates, protocols, and IEC 62304-aligned test cases.
- Review executed test cases and collaborate with Quality Assurance to resolve findings.
- Approve test reports and ensure documentation compliance.
- Establish and maintain V&V traceability across software and lab instruments.
- Manage cadence and prioritization of V&V activities across programs.
- Travel to the Foresight lab in Boulder, CO for testing and collaboration.
Requirement:
- 4+ years in software verification and validation for regulated medical device software.
- 3+ years designing and executing verification tests for NGS bioinformatics pipelines.
- 2+ years of testing experience in cloud environments (AWS or GCP).
- Direct knowledge of ISO 13485 and IEC 62304 design controls.
- Experience working with bioinformaticians, software engineers, and clinical lab teams.
- Background in bioinformatics, computational biology, or a related field.
- Excellent communication skills for technical documentation.
Benefits:
- Comprehensive medical, dental, vision, life, and disability plans.
- Free testing for employees and their families, fertility care benefits.
- Pregnancy and baby bonding leave, 401k benefits, commuter benefits, and more.
Required Languages
🇬🇧 English