Quality Engineer, Senior Staff (Risk Management)
Position Title: Quality Engineer, Senior Staff
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 (Risk Management) role will play a critical part in structuring the Design History File, strengthening product risk management, and partnering with R&D to translate existing development work into FDA-ready documentation and controls. This role will collaborate with cross-functional teams and engineers to implement complex maintainability expectations and drive a quality culture.
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.
- Drive design controls remediation: DHF structure, missing documentation, review alignment
- Partner with R&D to convert existing development outputs into compliant design inputs, outputs, and verification evidence
- Identify gaps and prioritize IDE-critical documentation
- Support IDE submission readiness and audit preparedness
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.
- 8-12 years QE in medical devices
- Hands-on design controls remediation experience
- Risk management ownership experience
- Experience supporting submissions or inspections after gaps existed
- Comfortable in fast-paced, imperfect environments
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.