Software Quality Engineer
Company DescriptionRelief Cardiovascular, part of the inQB8 Medical Technologies portfolio, is pioneering the development of a novel smart implant designed to aid heart failure patients. The Relief System is the first transcatheter implant that actively decongests patients suffering from heart failure. This breakthrough targets millions of individuals, particularly those with diuretic resistance, offering a transformative solution for their care.Role DescriptionThe Senior/Staff Software Quality Engineer will play a critical role in building and maintaining the software quality foundation for the Relief System, an advanced Class III implantable cardiovascular device. This individual will be at the intersection of quality systems, software development, and regulatory compliance. You will establish and maintain the software QMS, lead validation activities, and partner closely with the engineering team to ensure that firmware and software meet the highest standards of safety and efficacy. This is a full-time, on-site position based at our headquarters in Irvine, CA.Qualifications• Implement, maintain, and continuously improve the software Quality Management System (QMS) per ISO 13485 and FDA requirements, including ownership of software-related SOPs, work instructions, and document control.• Develop, execute, and maintain software validation protocols and reports in compliance with IEC 62304 and 21 CFR Part 820.• Support medical device cybersecurity activities in alignment with FDA cybersecurity guidance and IEC 81001-5-1, including contributing to the cybersecurity risk assessment, Software Bill of Materials (SBOM) maintenance, and vulnerability monitoring for third-party software components.• Support EU MDR Technical Documentation for software, ensuring software lifecycle documentation meet notified body expectations.• Ensure software development and validation activities comply with EU MDR General Safety and Performance Requirements (GSPR, Annex I), specifically requirements related to software as an active implantable device component.• Lead design verification activities for software and firmware components of the Relief System.• Plan and conduct usability testing activities per IEC 62366 to support human factors engineering requirements.• Execute and oversee unit testing for firmware and electrical software components in collaboration with the development team.• Manage and maintain software documentation using GitHub, including version control, change management, and traceability.• Create and manage SPDX files for software bill of materials (SBOM) to ensure component-level traceability.• Ensure supplier compliance for all software-related vendors and third-party components through qualification and monitoring activities.• Own complaint handling for software and firmware-related product complaints, including investigation, root cause analysis, and documentation in the quality system.• Support FDA inspection readiness by maintaining audit-ready software quality documentation and records.• Collaborate with cross-functional teams (Embedded Software, Electrical Engineering, Regulatory Affairs, Clinical) to drive quality throughout the software product lifecycle.Preferred Skills & Hands-On Experience• Strong working knowledge of IEC 62304 (Software Lifecycle), IEC 62366 (Usability Engineering), and 21 CFR Part 11.• Hands-on experience with GitHub for version control and software change management in a regulated environment.• Experience generating and managing SPDX files and software bill of materials (SBOM).• Familiarity with firmware and embedded software development processes.• Familiarity with EU MDR 2017/745 software-specific requirements including GSPR Annex I and Technical Documentation Annex II• Background in Class III medical devices or other safety-critical regulated industries.• Experience with risk management per ISO 14971.• Proficiency with electronic quality management systems (eQMS) and document control platforms.Education & Work Experience• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or a related field.• Minimum of 5 years of experience in software quality engineering, ideally within Class II or Class III medical devices.• Prior experience supporting FDA inspections or notified body audits strongly preferred.• Prior experience supporting EU MDR inspections Compensation and BenefitsOur salary ranges are determined based on role, level, and relevant industry factors. Compensation for this position will be based on an individual’s job-related knowledge, skills, experience, education, and certifications. We also assess internal equity and current market conditions when determining salaries.• Base salary range: $120,000 – $175,000• Employee stock options• Comprehensive benefits package (health, dental, vision, 401k, etc.)