
Senior Software V&V Engineer
Foresight Diagnostics Inc.about 1 month ago
Remote, WorldwideSenior / Mid Level
Base Salary
$145k - $175k/yr
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 and lab automation methods.
- Design and execute software verification tests for NGS bioinformatics pipelines.
- Develop and maintain clear, complete, and audit-ready test documentation.
- Review executed test cases and collaborate with Quality Assurance to resolve findings.
- Approve test reports and ensure compliance with design controls.
- Establish and maintain V&V traceability across software and lab instruments.
- Manage the cadence and prioritization of V&V activities across programs.
- Travel to the Foresight lab in Boulder, CO for testing and collaboration.
Requirements
- 4+ years of experience in software verification and validation for regulated medical devices.
- 3+ years of experience designing and executing tests for NGS bioinformatics pipelines.
- 2+ years of testing experience in cloud environments like AWS or GCP.
- Direct knowledge of ISO 13485 and IEC 62304 design controls.
- Experience working with bioinformaticians, software engineers, and clinical lab teams.
- Prior work experience in bioinformatics, computational biology, or a related field.
- Excellent written and verbal communication skills for technical documentation.
Benefits
- Competitive annual base compensation of $145,000 - $175,000.
- Comprehensive benefits package including medical, dental, and vision.
- Flexible PTO and paid holidays.
- Parental leave.
- 401(k) with company match.
Tech Stack
AWSGoogle Cloud Platform