Senior Software V&V Engineer

Foresight Diagnostics is seeking a Senior Software V&V Engineer to join their team. The role involves leading verification and validation activities for regulated medical device software, with a focus on bioinformatics pipelines and NGS analysis. The successful candidate will have a strong background in bioinformatics or computational biology and experience with IEC 62304 and ISO 13485 design controls.

Requirements

• 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 — applied experience, not just familiarity.
• 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 — this is a hard requirement for this role.

Benefits

• Medical, dental, and vision
• Flexible PTO and paid holidays
• Parental leave
• 401(k) with company match