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Tier-1 brand and metro location raise density, but senior regulated V&V niche reduces qualified applicant pool.
Strong regulatory, NGS and IVD domain expertise required, limiting cross-industry transferability.
Explicit 10+ years, 8+ V&V experience, and mandated regulated-software standards make filters highly strict.
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Lead design and implementation of software verification and validation strategies for next-generation sequencing (NGS) analytics and medical device software products.
Manage and mentor a team of bioinformatics and software test engineers, establishing quality standards and KPIs to track software product quality throughout the lifecycle.
Act as primary liaison with external partners and coordinate with internal stakeholders to define testing scope, plan, and execute verification activities in regulated environments.
Minimum 10+ years work experience, Masters/PhD preferred; Bachelor's acceptable with strong industry productivity track record.
At least 8 years experience in software verification and validation testing in medical device or biotech domain.
Strong knowledge of NGS-based regulated software, IVD assay development, informatics data pipelines, and applicable regulatory standards (ISO 13485, IEC 62304, 21 CFR 820).
Experience leading software quality engineering teams, preferably multi-site and cross-functional, with practical leadership in modern software development methodologies.
Experienced strategic leader comfortable owning end-to-end quality assurance practices in regulated diagnostics software products.
Operates effectively in fast-paced, dynamic, highly regulated environments requiring risk mitigation and quality improvements.
Skilled collaborator with senior leadership, cross-functional teams, and external partners to align testing strategies with regulatory and product goals.