Senior Quality Software Engineer, NPD - IHFM
Edwards LifesciencesBase Salary
$108k - $153k/yr
Responsibilities
- Coordinate and oversee software design activities across the IHFM product suite, including applications, microservices, data platforms, UI, signal processing, DevOps, security, and operating systems.
- Develop and deploy custom software test and automation systems and define test methods for new product development.
- Create software verification strategies, testing methods, and V&V plans based on product requirements and software design.
- Lead complex end-to-end and system integration testing across applications, platforms, and data systems.
- Drive defect triage, quality assessment, root-cause analysis, and software quality input into architecture and risk discussions.
- Review test plans, protocols, and reports in Azure DevOps while supporting compliance with FDA, IEC 62304, ISO 13485, and ISO 14971.
- Partner with hardware, mechanical, clinical, quality, product, and R&D teams on requirements, design, manufacturability, validation, and regulatory submissions.
- Provide technical leadership, stakeholder influence, and communication of complex concepts across cross-functional teams.
Requirements
- Bachelor's degree in engineering or a related field with 4 years of related industry experience, or a master's degree or equivalent with 3 years of experience, or a Ph.D. or equivalent with 0 years of experience.
- Experience with IEC 62304 medical-device software, medical-device regulations, software life-cycle processes, design controls, V&V, and compliant documentation.
- Experience with hardware-software integration, system testing, test design, data acquisition, analysis, and hardware/software protocols.
- Proficiency with Azure DevOps for test management, traceability, and Agile execution.
- Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, FDA and IMDRF frameworks, and Software as a Medical Device.
- Experience or knowledge in cybersecurity, interoperability, wireless or BLE testing, UI, and connected devices.
- Exposure to Jira, Jama, Codebeamer, Helix ALM, or TestRail, with relevant certifications such as ISTQB Advanced, CSTE, or ASQ preferred.
- Strong technical writing, troubleshooting, analytical, organizational, collaboration, interpersonal, and problem-solving skills, with the ability to work independently and cross-functionally.
- Background in cardiac, hemodynamic, or implantable medical technologies is preferred.
Benefits
- Competitive salary, performance-based incentives, and a wide variety of benefits programs for employees and their families; the California base pay range is $108,000 to $153,000.
About Edwards Lifesciences
Edwards Lifesciences (NYSE: EW), 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. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Contact Us We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm. All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.