Senior Quality Software Engineer, NPD - IHFM

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). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.