Quality Engineer, Senior Staff (Software)

Enchannel Medical • Irvine, CA

8h

About The Position

Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes. Position Overview The Quality Engineer, Senior Staff (Software) role will serve as the software quality lead for New Product Development (NPD) projects. This role partners closely with cross functional teams, including software, systems, test engineering, and other stakeholders, to ensure high quality, compliant software releases across the product lifecycle.

Requirements

• Bachelor’s degree in Engineering, Science, or a technical field with 8+ years of software quality experience; OR Advanced degree in Engineering, Science, or a technical field with 6+ years of software quality experience.
• Experience in software quality assurance, including design controls and testing for software driven medical devices.
• Working knowledge of IEC 62304, FDA software validation guidance, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601 1, and MDD/MDR.
• Expertise in risk assessment, requirements management, traceability, defect tracking, and configuration management.
• Experience leading risk related discussions and translating product hazards into potential user harms.
• Strong organizational, problem solving, and analytical skills.
• Ability to manage multiple priorities and adapt to changing project needs.

Nice To Haves

• ASQ Certified Software Quality Engineer (CSQE) and/or Green Belt in Lean/Six Sigma.

Responsibilities

• Provide software quality leadership through NPD activities, including:
• NPD planning and requirements development
• Architecture and design reviews
• Software risk management, including system level risk reviews, FMEA, and safety impact assessments
• Verification and validation (V&V) planning, execution, and reporting
• Human Factors input, verification, and validation support
• Oversight of automated testing strategy and execution
• Software defect evaluation and disposition
• Product performance assessments and quality trending
• CAPA input and support
• Design History File (DHF) audits
• NPD management reviews
• Provide quality oversight for non-product software requirements and verification.
• Support internal and external regulatory inspections.
• Mentor junior quality engineers, promoting strong quality engineering practices.
• Collaborate in a dynamic team environment centered on delivering safe, effective, compliant products.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior