Quality Engineer, Senior Staff (Software)
Position Title: Quality Engineer, Senior Staff (Software)
Department: Quality
Reports to: Quality, Senior Manager
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.
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.
- 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.
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 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.
Preferred Qualifications:
- ASQ Certified Software Quality Engineer (CSQE) and/or Green Belt in Lean/Six Sigma.
- 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.
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.