Jobs / United States / Natera INC
Director, ECD Development
Natera INC · 🇺🇸 San Carlos, CA
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 48 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 12 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Natera INC paid sponsored hires in similar roles1 certified filing for “Senior Director, Business Development” (Sales Managers) in CA: $246k–$246k, median $246k. Most were filed at wage level IV (100%) — 4 lottery entries, ≈61% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Natera INC
The US Department of Labor certified 48 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 12 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Natera INC →
About the role
POSITION SUMMARY: Join Natera as the Director of Development for our Early Cancer Detection (ECD) In Vitro Diagnostic (IVD) products. You will take ownership of the development, verification, and validation of our early cancer detection (ECD) Next Generation Sequencing products from feasibility exit through regulatory submission and post-market support. Every test represents a real person, and you will lead a team of scientists and managers to execute the performance data packages supporting PMA submissions. You will serve as the technical subject matter expert in FDA interactions, partnering across functions to deliver design-controlled diagnostic products that directly impact patient care. PRIMARY RESPONSIBILITIES: • Own the execution of the technical strategy and phase-gated process of of development, design verification, and validation studies for ECD IVD devices utilizing cfDNA, methylation and other potential analytes • Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements • Take ownership of the analytical performance strategy (limit of blank/detection, precision, linearity, interference, stability) for ECD assays, partnering directly with Regulatory Affairs (RA), biostatistics, bioinformatics and research teams • Contribute to the robust transfer of assays to the commercial laboratory and manufacturing in support of the design transfer and operations teams • Partner with clinical and biostatistics leaders on statistical analysis plans required for approvable device performance claims in clinical intended-use populations • Think team by partnering directly across bioinformatics, biostatistics, software engineering, clinical, regulatory, and commercial functions to align development efforts with business goals, and drive resourcing and go/no-go recommendations at phase gates • Deliver the analytical performance data package supporting Class III PMA submissions, developing a comprehensive approval strategy with RA • Serve as the technical subject matter expert in correspondence and meetings with the FDA, defending performance evidence using data • Treat Quality Management System (QMS) requirements (ISO 13485:2016, FDA QMSR 21 CFR Part 820, ISO 14971, IEC 62304) and regulatory guidance as the foundation of product development rather than a final check • Build, develop, and retain a high-performing organization of scientists and managers, optimizing program budgets and external vendor partnerships • Use data to identify technical and timeline risks, including ISO 14971 risk management deliverables, making risk-based decisions on mitigation and escalation REQUIRED QUALIFICATIONS: • Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life Sciences, or a related field; an MS with additional relevant industry experience will be considered • 6+ years of experience in IVD or diagnostic device development under design controls • 5+ years of experience directing scientific or technical teams KNOWLEDGE, SKILLS, AND ABILITIES: • Deep technical expertise with complex NGS-based diagnostic assays, including assay design, analytical validation, and transfer to a commercial laboratory or manufacturing • Demonstrated direct experience in FDA interactions (e.g., Pre-Submission meetings) for a molecular diagnostic or NGS-based device • Experience in liquid biopsy or molecular diagnostics for clinical oncology, specifically cfDNA-based detection of low-abundance signals at high specificity • Push for clarity and outcome-driven action across the organization, with a solutions-oriented approach to both technical challenges and cross-functional team dynamics • Working knowledge of FDA premarket pathways for high-complexity IVD approvals • Deep kno