Software Validation and Verification, Manager or Senior Manager - 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 Manager or Senior Manager for the role of Software Verification and Validation Engineer 

to join our R&D Software Team. In this pivotal position, you will ensure the quality and reliability of our software products. Your leadership and strategic vision will be essential in guiding the team, setting goals, and driving continuous improvement. Your expertise will be crucial in evaluating engineering systems, analyzing results, and maintaining testing equipment, directly impacting the safety and performance standards of our medical device and technology. The ideal candidate has leadership skills, problem-solving abilities, and a desire to contribute real-world solutions while collaborating with cross-functional teams in our dynamic start-up environment.

What you will be doing:

• Establish and maintain VnV framework: Set up and sustain a robust Verification and Validation environment to ensure consistent testing processes.
• Develop and execute quality tests: Design and implement comprehensive tests, create automated testing frameworks, and maintain testing equipment for accurate results.
• Collaborate with cross-functional teams: Work with various departments to refine test criteria, gather requirements, and optimize software performance.
• Troubleshoot and resolve issues: Identify and resolve validation issues, ensuring compliance with safety and quality standards throughout the testing process.
• Maintain VnV documentation: Create and update detailed Verification and Validation documentation for regulatory submissions and internal use.
• Leadership and Team Management: Demonstrated ability to lead and manage a team, providing guidance, mentorship, and fostering a collaborative work environment.

What we are looking for: 

• Educational Background: Bachelor's degree in computer science, electrical engineering, or a related field, with a strong foundation in software validation.
• Relevant Experience: Prior experience as a validation engineer or in a similar role, focusing on software validation, with comprehensive knowledge of the full lifecycle experience in the medical device industry.
  
• Technical Proficiency: Proficient in statistical analysis software, familiarity with MATLAB, Agile methodology, and A-SPICE reference models; skilled in validating, debugging, and configuring software products within an Agile environment.
• Testing and Compliance: Experience conducting functional, interoperability, multi-dimensional scale, and performance tests; ability to create test plans for multi-vendor environments, optimize test coverage, and ensure adherence to manufacturing processes and safety regulations. 
• Quality and Documentation: Commitment to continual improvement of quality processes and test beds, with expertise in generating validation documentation, plans, and reports, and a proven track record in troubleshooting validation issues and providing feedback to the development team.

Join EnChannel Medical and contribute to the advancement of our cutting-edge medical devices, ensuring they meet the highest standards of safety and performance.

What we offer:

Amazing people and culture

Competitive Salary

Comprehensive benefits plan and 401K with company matching

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.