Senior Quality Software Engineer, NPD - IHFM

Regulatory Jobs; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards is seeking a software quality-focused engineer to drive design across the Implantable Heart Failure Management product suite. You will work with hardware, clinical, and quality teams to ensure compliant software, robust V&V, and effective risk management.

You will develop test strategies, review plans in Azure DevOps, and lead cross-functional efforts to meet FDA, IEC 62304, ISO 13485, and ISO 14971 requirements. A strong SDLC background is essential.

Qualifications

• Bachelor's Degree in Engineering or related field with 4 years’ experience.
• Master's Degree or equivalent with 3 years’ experience.
• Ph.D. or equivalent with 0 years’ experience (Preferred).
• Experience with IEC 62304 Medical Device Software.
• Experience with hardware–software integration.
• Experience in medical device regulations standards and SDLC documentation.

Responsibilities

• Coordinate software design activities across IHFM product suite and platforms.
• Develop test strategies and V&V plans based on requirements and design.
• Support review of plans and reports in Azure DevOps to FDA/IEC/ISO standards.
• Lead QA activities with cross-functional teams in an Agile environment.
• Champion quality and risk discussions in architecture decisions.

Skills

Software design

Regulatory compliance

Azure DevOps

V&V

SDLC documentation

IEC 62304

ISO 13485

ISO 14971

Education

Bachelor's Degree in Engineering or related field

Master's Degree or equivalent

Ph.D. or equivalent

Tools

Azure DevOps

Jira

Jama

Codebeamer

Helix ALM

TestRail

Job description

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. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you’ll make an impact:

• 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).
• Maintain a strong understanding of design considerations while contributing to and influencing Class B software system design
• 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.
• 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.
• Perform other duties and responsibilities as assigned by leadership.

What you’ll need (Required):

• 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

What else we look for (Preferred):

• Experience with IEC 62304 Medical Device Software
• Experience with hardware-software integration.
• Experience in software and hardware system testing, test design, data acquisition and analysis.
• Strong technical writing skills.
• Experience in Medical Device regulations standards and SW design, life cycle and V&V
• Knowledge of HW/SW protocols
• UI Experience
• Proficiency with Azure DevOps (ADO) for test management, traceability, and Agile execution.
• Strong technical writing skills and the ability to collaborate effectively across engineering, quality, and regulatory teams.
• Familiarity with design control processes for medical devices or Software as a Medical Device (SaMD).
• Deep understanding of SDLC documentation, including requirements, design controls, V&V evidence, and traceability.
• Experience developing compliant documentation aligned to FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971.
• Strong familiarity with global regulatory frameworks for medical devices and SaMD (FDA, IMDRF).
• Experience with cybersecurity, interoperability, or wireless (e.g., BLE) testing for connected devices.
• Exposure to modern ALM and traceability tools (Jira, Jama, Codebeamer, Helix ALM, TestRail).
• Background in cardiac, hemodynamic, or implantable medical technologies.
• Relevant certifications such as ISTQB Advanced, CSTE, or ASQ.
• Troubleshooting mindset, able to systematically and effectively break down a system or process into subparts to identify failure mechanisms.
• Proactive attitude, excellent teamwork and interpersonal skills including negotiating and relationship management.
• Solid problem-solving, organizational, analytical, and critical thinking skills.
• Must work well both independently and as a member of a cross-functional team in a dynamic environment.
• Capable to quickly learn and interpret complex test systems.
• Must be a highly motivated self-starter who is driven to achieve quality and value-add results. Candidate must seek direction when appropriate.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.