about 3 hours ago
Remote, United StatesSenior / Mid Level
H1B Sponsor
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 regularly to the Boulder lab 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 cross-functionally with bioinformaticians and clinical teams.
- Prior work experience in bioinformatics or computational biology is required.
- Excellent communication skills for translating technical findings into documentation.
Benefits
- Comprehensive medical, dental, vision, life, and disability plans.
- Free testing for employees and their immediate families.
- Fertility care benefits and pregnancy/baby bonding leave.
- 401k benefits and commuter benefits.
- Generous employee referral program.