Senior Design Assurance/Quality Engineer - ENCHANNEL MEDICAL LTD

EnChannel Medical provides the opportunity to transform the future of cardiac arrhythmia through the power of technology. We are here to solve real-world problems and maximize global impact, fueled by the idea that our products will save lives, including our loved ones.

We are seeking a highly skilled and motivated Quality Lead to join our dynamic team. In this role, you will be responsible for ensuring the highest standards of quality across multiple electrophysiology (EP) catheter programs. Your expertise will guide our efforts from design through post-market surveillance, ensuring our products meet stringent quality and regulatory requirements.

What you will be doing:

• Quality Leadership: Act as the Quality Lead for multiple EP catheter programs, providing direction and oversight to ensure product excellence.
• Technical Documentation: Construct comprehensive Technical Documentation for Medical Device Files, including Requirements Documents, Risk Management plans, Protocols, IFUs/User Manuals, V&V plans, and Traceability Matrices.
• Test Method Validation: Drive assessments and validations for design verification test methods, ensuring robust and reliable testing processes.
• Testing and Reporting: Participate in engineering feasibility testing and official product testing, overseeing third-party testing where appropriate, and generating detailed reports with risk-based statistical analysis.
• Post Market Surveillance: Support post-market surveillance activities, manage complaints, and continuously improve product quality.

What we are looking for:

• Experience and Education: 5 + years of experience in quality assurance within medical device industry or regulated industry (preferably aerospace), and a Bachelor's degree in an engineering or life sciences or related discipline; or equivalent combination of education and experience.
• Quality Assurance Skills: In-depth knowledge of medical device regulations and standards, including ISO 13485 and FDA 21 CFR Part 820.
• Risk Managment: Proven experience with electrophysiology (EP) catheter programs and proficiency in risk management, test method validation, and statistical data analysis
• Leadership Skills: Strong leadership and communication skills, with excellent technical writing abilities and attention to detail, capable of working effectively in a collaborative team environment

What we offer:

• Amazing people and culture
• Competitive Salary
• Comprehensive benefits plan and 401K with company matching
• Stocked kitchen with snacks and drinks
• Casual dress and start-up work environment
• Wellness and fitness programs

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.