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!

Who we are looking for:

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

Responsibilities:

• Quality Leadership: Act as the Software 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 approval of various software documentation including Software Development Plans, Software Requirements, and Software Architecture and Detailed Design documents, unit test reports, and integration testing. Collaborate with cross-functional team to ensure documentation is accurate, concise and complete, and meets applicable company procedures and external regulations.
• Risk Management: Lead Software Hazard Analysis activities to identify and manage software associated risks.
• Software Verification: Lead System Level Software Verification activities to demonstrate software is performing according to requirements. This includes creation of test plans, test protocols, execution of test cases, generation of test reports, and development of trace matrices.

What we are looking for:

• 8+ years of experience in software quality assurance for Class II/III medical devices
• Bachelor's degree in computer science, computer engineering, or related discipline
• In-depth knowledge of medical device regulations and standards, including IEC 62304, ISO 13485 and FDA 21 CFR Part 820.
• Proven in-depth knowledge of Software/Test development lifecycle methodologies, principles and practices
• Familiarity with Python Automation Framework
• Familiar with C++ and C#
• Familiar with Git, and ADO
• 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.