Who we are:

EnChannel Medical is an early-stage med device startup focused on the electrophysiology (EP) market (Cardiac Mapping and Pulsed Field Ablation). Our mission is to transform the future of cardiac arrhythmia management through the power of technology. Pulsed Field Ablation (PFA) devices have revolutionized atrial fibrillation (AFib) treatment and are currently one of the fasted growing Markets in Medtech!

Responsibilities:

We are seeking a highly skilled and motivated Quality Engineer to join our dynamic team. In this role, you will be responsible for ensuring the highest standards of Quality and Compliance are achieved across multiple new product development projects. You will pe part of the core team and help oversee development efforts from the early stages (concept/feasibility) thru commercialization.

• Quality Leadership: Act as the Quality Lead for one or more EP R&D programs, providing direction and oversight to ensure products are safe and effective and corresponding Design Control requirements are met.
• Technical Documentation: Review and approve Technical Documentation including Plans, Specifications, Protocols, and Reports.
• Risk Management: Lead Risk Management activities to assess and manage Design, Process, and Use related risks.
• Test Method Validation: Lead test method validation activities for design and/or process test methods.

What we are looking for: (requirements)

• 8+ years of experience in quality assurance for Class II/III medical devices
• Bachelor's degree in engineering or related discipline
• In-depth knowledge of medical device regulations and standards, including ISO 14971, ISO 13485 and FDA 21 CFR Part 820.
• Excellent communication and collaboration skills

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.