Edwards Lifesciences
Senior Quality Software Engineer, NPD - IHFM
USA - California – Irvine · Senior
Stay score
odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$15,843 more — $123,843 — moves this role to Level II and 2 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $123,843 would place this position at wage Level II. That figure is within the posted range, and I'd like to target it. This role classifies under "Software Developers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Software Developers (15-1252) · Bakersfield-Delano, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
Employer immigration record
from this employer's Department of Labor filings
Green-card follow-through: 50%
Reported a layoff in this occupation
Files H-1B transfers
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Many structural heart patients suffer from heart failure with limited options.
- Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention.
- Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members.
Responsibilities
- Coordinate and oversee software design activities across software elements across the IHFM product suite-including digital applications (mobile/web), microservices-based platforms (.NET Core, Java, Python, GoLang, Rust), and modern data platforms (Databricks; Python/Scala pipelines).
- Coordinate and oversee software design activities across UI, signal processing, DevOps, product security, operating systems, and related application areas
- Work closely with other development engineers (hardware, mechanical, clinical and quality) to ensure the system is designed and delivered with appropriate requirements.
- Drive the development and deployment of custom test systems SW / automation SW, and test methods concurrently with new product development.
- Develop SW verification strategy, testing methods and V&V plans based on product requirements and SW design including writing tests that challenge the system and its requirements and advocate for test approaches that have highest impact.
- Support complex end-to-end and system integration testing across applications, platforms and data systems.
- Drive defect triage, quality assessment, and root-cause analysis in close partnership with cross-functional engineering, product, and quality teams.
- Support review of test plans, protocols, and reports in Azure DevOps (ADO), ensuring alignment with FDA, IEC 62304, ISO 13485, and ISO 14971 standards.
- Influence product and platform design by bringing a strong software quality perspective to architecture and risk discussions.
- Partner with R&D to shape system requirements and contribute to robust software and system design.
Requirements
- What you'll need (Required):
- Experience with hardware-software integration.
- Proficiency with Azure DevOps (ADO) for test management, traceability, and Agile execution.
- Experience with cybersecurity, interoperability, or wireless (e.g., BLE) testing for connected devices.
- Must be a highly motivated self-starter who is driven to achieve quality and value-add results. Candidate must seek direction when appropriate.
Nice to have
- Python/Scala pipelines).
- Maintain a strong understanding of design considerations while contributing to and influencing Class B software system design
- Champion Agile and Lean methodologies to embed quality early in the development lifecycle and improve delivery predictability.
- Ensure manufacturability is considered early in NPI programs while supporting successful regulatory submissions through strong validation practices.
- Provide technical leadership, influence stakeholders, and confidently present complex ideas to diverse audiences.
- Bachelor's Degree in Engineering or related field, 4 years' experience related industry experience or
- Master's Degree or equivalent in Engineering or related field, 3 years' experience related industry experience or
- Ph.D. or equivalent in Engineering or related field, 0 years' experience related industry experience Preferred
Compensation
- For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced).
Benefits
- Experience with IEC 62304 Medical Device Software
- Experience in Medical Device regulations standards and SW design, life cycle and V&V
- Familiarity with design control processes for medical devices or Software as a Medical Device (SaMD).
- Strong familiarity with global regulatory frameworks for medical devices and SaMD (FDA, IMDRF).
- Background in cardiac, hemodynamic, or implantable medical technologies.
Company info
- Join us and be part of our inspiring journey.
This listing is sourced directly from Edwards Lifesciences's careers page and normalized into a canonical job model.