Own verification and validation activities across Foresight's software portfolio — working closely with bioinformaticians, software engineers, and clinical laboratory teams to ensure every system is tested thoroughly and documented completely.
Align all software testing processes with IEC 62304 and ISO 13485 design control requirements, and ensuring the team operates consistently within that framework.
Oversee V&V activities for pipeline software, lab automation methods, reagent QC software, LIMS/LIS tools, and select laboratory instruments.
Design and execute software verification tests for NGS bioinformatics pipelines — including tests for end-to-end analysis workflows and individual NGS algorithms.
Develop and maintain test templates, test protocols, and IEC 62304-aligned test cases that are clear, complete, and audit-ready.
Review executed test cases, assess variances, and collaborate with the Quality Assurance team to resolve and document findings appropriately.
Approve test reports and ensure full documentation compliance under design controls.
Establish and maintain V&V traceability across device software, lab automation tools, and lab instruments — including oversight of software traceability matrices across all device software components.
Manage the cadence, prioritization, and execution of V&V activities across concurrent programs.
Traveling to the Foresight lab in Boulder, CO on a regular basis to support testing activities, lab integration work, and cross-functional collaboration.

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.
Excellent written and verbal communication skills, with the ability to translate complex technical findings into clear, compliant documentation.

Benefits

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

software verificationsoftware validationtest designNGS bioinformaticstest protocolstest casestraceability matricescloud testingregulatory compliancedocumentation compliance

Soft Skills

communicationcollaborationproblem-solvingattention to detailorganizational skills