POSITION OVERVIEW

The Quality Engineer, Senior Staff (Systems) will support the design, development, transfer, and commercialization of Class II and Class III interventional catheter systems. This position integrates Systems Engineering and Software Quality Engineering responsibilities to support the development of complex electrical medical equipment and systems, including hardware, firmware, embedded software, and Software as a Medical Device (SaMD). The engineer will collaborate with the team on product realization deliverables such as system architecture, design control, quality assurance software testing, and risk management activities, ensuring compliance with regulatory standards and supporting successful product launch activities for Class II and Class III devices and systems.

EDUCATION, EXPERIENCE AND SKILLS REQUIRED

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role.

• Bachelor’s degree or higher in Systems, Electrical, Biomedical, Mechanical, Software Engineering, or Computer Science.
• 8–12 years of experience in systems engineering or medical device development.
• Strong working knowledge of IEC 60601-1, IEC 62304, IEC 62366, ISO 13485, ISO 14971, ISO 62344, MDR, and FDA regulations, including cybersecurity.
• Experience leading subsystem integration, requirement management, formal verification, and hands-on application of software lifecycle design controls and risk management for medical electrical devices/systems.
• Extensive experience creating, supporting, and approving design control and risk management deliverables while ensuring regulatory compliance.
• Experience in QA roles, including collaboration on software test planning, automation, system integration testing, defect management, test execution, reporting, and documentation.
• Familiarity with system and product requirements and lifecycle product management tools (e.g., Jama, DOORS) and software operational platforms (e.g., DevOps).
• Strong problem-solving, analytical, and communication skills with high attention to detail and adaptability.
• Demonstrated ability to work effectively with Regulatory, Research and Development, and Software teams.
• Strong understanding of Class II and III devices and their interface and integration into medical device electrical equipment/systems.
• Extensive hands-on experience in test planning and execution, defect management, and system integration testing.
• Preferred Qualifications
• Experience with Software as a Medical Device (SaMD) and cloud-based platforms (AWS, Azure).
• Experience with SAFe or hybrid development methodologies and tools such as DOORS, Jama, or Polarion.
• Certified Software Quality Engineer (CSQE), Six Sigma Black Belt, or equivalent certification.
• Experience integrating AI/ML in medical software.
• Knowledge and application of cybersecurity standards (e.g., ISO/IEC 27001, FDA premarket guidance).
• Experience in automation testing using tools such as Selenium or JMeter.
• Proficiency in programming languages such as Java and Python.
• Experience with test management tools such as TestRail or TestLink.
• Familiarity with Software Development Life Cycle (SDLC) and authorship/creation of software deliverables.
• Strong understanding and use of Scrum, Kanban, and Waterfall methodologies for verification and validation.
• Hands-on engineering experience with medical device electrical systems and single-use sterilized disposables from concept to commercialization, including software product lifecycles for Class II and III devices.

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training.
EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.
Only qualified candidates will be contacted

DUTIES AND RESPONSIBILITIES

The following are the major responsibilities needed for the role. Additional responsibilities, tasks, and duties will be assigned and required as needed.

• Collaborate, support, and approve system architecture and design realization from concept to commercialization for an electromechanical system compliant with IEC 60601.
• Translate user needs into system and software requirements with full traceability for verification and validation testing.
• Create, conduct, and lead system-level risk assessments; lead risk management documentation including Hazard Analysis, FMEA, and cybersecurity evaluations; and ensure risk mitigations are applicable and complete.
• Collaborate, support, and approve system-level requirements and design control documentation throughout all product realization phases, ensuring traceability from user needs through design verification, validation, transfer, and commercial release.
• Lead, support, and coordinate risk analysis to ensure design compliance with IEC 60601-1, ISO 14971, and IEC 62304.
• Lead, create, and support system verification plans and protocols; execute formal verification testing; and prepare formal reports.
• Collaborate with cross-functional teams to ensure seamless integration of hardware, firmware, and software components.
• Develop and maintain design documentation including the Design History File (DHF), architecture diagrams, and traceability requirements matrices.
• Collaborate and support usability/human factors studies and product integration in compliance with IEC 62366-1.
• Support and participate in technical, design, and phase reviews.
• Support regulatory submissions (e.g., 510(k), CE Mark) by facilitating system-level documentation.
• Participate in internal and external audits, including FDA and notified body inspections.
• Software Quality Engineering:
• Support software quality, product, and design plans, including verification and validation protocols and reports, and conduct quality assurance software testing.
• Ensure compliance with IEC 62304, ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• Create software risk management plans; conduct and lead software risk analysis, hazard analysis, and FMEAs.
• Support test plans, execute test cases and test scripts, and maintain documentation.
• Lead and support debugging activities, including identification, tracking, correction, and documentation.
• Execute testing for manual and automated processes, including UI functionality and regression testing.
• Validate interactions between software components and systems.
• Ensure end-to-end functionality across platforms.

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role.

• Bachelor’s degree or higher in Systems, Electrical, Biomedical, Mechanical, Software Engineering, or Computer Science.
• 8–12 years of experience in systems engineering or medical device development.
• Strong working knowledge of IEC 60601-1, IEC 62304, IEC 62366, ISO 13485, ISO 14971, ISO 62344, MDR, and FDA regulations, including cybersecurity.
• Experience leading subsystem integration, requirement management, formal verification, and hands-on application of software lifecycle design controls and risk management for medical electrical devices/systems.
• Extensive experience creating, supporting, and approving design control and risk management deliverables while ensuring regulatory compliance.
• Experience in QA roles, including collaboration on software test planning, automation, system integration testing, defect management, test execution, reporting, and documentation.
• Familiarity with system and product requirements and lifecycle product management tools (e.g., Jama, DOORS) and software operational platforms (e.g., DevOps).
• Strong problem-solving, analytical, and communication skills with high attention to detail and adaptability.
• Demonstrated ability to work effectively with Regulatory, Research and Development, and Software teams.
• Strong understanding of Class II and III devices and their interface and integration into medical device electrical equipment/systems.
• Extensive hands-on experience in test planning and execution, defect management, and system integration testing.
• Preferred Qualifications
• Experience with Software as a Medical Device (SaMD) and cloud-based platforms (AWS, Azure).
• Experience with SAFe or hybrid development methodologies and tools such as DOORS, Jama, or Polarion.
• Certified Software Quality Engineer (CSQE), Six Sigma Black Belt, or equivalent certification.
• Experience integrating AI/ML in medical software.
• Knowledge and application of cybersecurity standards (e.g., ISO/IEC 27001, FDA premarket guidance).
• Experience in automation testing using tools such as Selenium or JMeter.
• Proficiency in programming languages such as Java and Python.
• Experience with test management tools such as TestRail or TestLink.
• Familiarity with Software Development Life Cycle (SDLC) and authorship/creation of software deliverables.
• Strong understanding and use of Scrum, Kanban, and Waterfall methodologies for verification and validation.
• Hands-on engineering experience with medical device electrical systems and single-use sterilized disposables from concept to commercialization, including software product lifecycles for Class II and III devices