Senior Software V&V Engineer

🕒 vor 5 Tagen

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

👷🏻‍♀️ Ingenieur

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Natera

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 2004

🏥 Gesundheitswesen

🧬 Biotechnologie

⚕️ Krankenversicherung

Healthcare • Biotechnology • Healthcare Insurance

Natera ist ein weltweit führendes Unternehmen in der Technologie der zellfreien DNA-Tests, das sich auf nicht-invasive genetische Tests und Diagnostik spezialisiert hat. Die innovativen Lösungen des Unternehmens konzentrieren sich auf Bereiche wie pränatales Screening, Krebstestung und Überwachung von Organtransplantationen. Durch den Einsatz fortschrittlicher Bioinformatik und DNA-Analysen bietet Natera medizinischen Fachkräften und Patienten entscheidende Informationen, um fundiertere medizinische Entscheidungen treffen zu können.

Beschreibung

• You'll 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. • Aligning all software testing processes with IEC 62304 and ISO 13485 design control requirements, and ensuring the team operates consistently within that framework. • Overseeing V&V activities for pipeline software, lab automation methods, reagent QC software, LIMS/LIS tools, and select laboratory instruments. • Designing and executing software verification tests for NGS bioinformatics pipelines — including tests for end-to-end analysis workflows and individual NGS algorithms. • Developing and maintaining test templates, test protocols, and IEC 62304-aligned test cases that are clear, complete, and audit-ready. • Reviewing executed test cases, assessing variances, and collaborating with the Quality Assurance team to resolve and document findings appropriately. • Approving test reports and ensuring full documentation compliance under design controls. • Establishing and maintaining V&V traceability across device software, lab automation tools, and lab instruments — including oversight of software traceability matrices across all device software components. • Managing 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.

🎯 Anforderungen

• 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. • Preferred testing experience with pipeline orchestration tools such as Nextflow. • Hands-on exposure to clinical laboratory workflows — CAP/CLIA environment experience is a meaningful advantage. • Familiarity with LIMS/LIS platforms in a regulated diagnostic context. • Experience contributing to or preparing for FDA submissions (510(k) or PMA) from a V&V documentation standpoint.

🏖️ Vorteile

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!