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Tier-1 employer and metro location increase visibility, but role's seniority and regulated NGS niche reduce applicant density.
Regulated IVD and NGS bioinformatics expertise is highly domain-specific and not easily transferable.
Explicit 10+ years, regulated IVD V&V mandates and leadership experience make filters stringent.
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Define and implement software testing strategies including automated and manual tests for advanced bioinformatics and NGS analytics software in regulated medical device environment.
Lead and mentor software and bioinformatics test engineers, establishing quality standards and KPIs across the software product lifecycle.
Collaborate with internal and external stakeholders to manage software verification and validation activities and ensure compliance with regulatory requirements.
Master's or PhD preferred; alternatively Bachelor's degree with minimum 10+ years work experience in relevant domain.
At least 8 years experience in software verification and validation testing, preferably in medical device or biotech industry.
Strong knowledge of NGS-based regulated software, IVD assay development, informatics data pipelines, and relevant standards (ISO 13485, IEC 62304, 21 CFR 820).
Proven leadership experience managing software quality engineering teams; experience with regulated product design controls.
Experienced leader comfortable managing cross-functional, multi-site test engineering teams in regulated medical device software development.
Strategic thinker skilled at risk identification and mitigation with full ownership of software quality outcomes.
Hands-on with modern software development processes in fast-paced, regulated environments, collaborating effectively with senior leadership and cross-disciplinary partners.