Staff/Principal Software Quality Assurance Engineer

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.
The Staff Software Quality Engineer will serve as a technical representative providing software quality expertise to product development teams. As an individual contributor, you will work with the product development function to act as a champion of Quality Assurance and Engineering activities throughout software development lifecycle. We are seeking an experienced Staff Software Quality Engineer to ensure our medical devices are developed in accordance with Recor Medical’s design control requirements and state of the art product standards.
You hold your work and teams to the highest quality standards and ensure that all corporate business requirements, regulations, and other standards are met, as applicable. This is a hands-on role where you will apply intensive, self-directed and diversified knowledge of engineering and quality principles for Recor Medical Product development projects. 

Responsibilities and Duties

• Develop and execute detailed test plans and test cases to verify software functionality, reliability, and performance.
• Author validation plans, protocols, software risk analyses for a medical device.
• Conduct regular regression testing, analyze results, and work closely with the development team for timely issue resolution.
• Manage and maintain bug tracking systems to document issues.
• Support and investigate customers’ complaints related to product software.
• Collaborate with users and developers to replicate and resolve bugs.
• Provide guidance for cybersecurity.
• Mange monitoring of software anomalies.

Requirements

• Bachelor’s degree in Computer Science, Software/Electrical engineering.
• Minimum of 7+ years of work experience in the medical device field.
• Knowledge of complex Quality Engineering processes and regulatory requirements. 
• Excellent ability to apply a systematic and analytical approach to problem-solving. 
• Advanced knowledge and ability to apply core concepts of engineering. 
• Ability to interpret internal/external business challenges and make recommendations for improvements to products, processes or services.
• Experience writing and executing validation/verification plans, protocols, and software risk analysis on Medical Devices.
• Working knowledge of FDA, Software Validation Guidance, 21 CFR part 820, IEC 62304, and IEC 82304-1.
• Experience in cybersecurity and Software Risks.
• Lead and participate in project teams assigned to new products.

COVID-19 vaccination requirementsAt Recor Medical, we care, we collaborate, we challenge, and we create. Pursuant to these core values, we are focused on the health and safety of our employees, as well as the teamwork essential for innovation of our pioneering technology. COVID-19 vaccines will be required for all ReCor US office employees effective June 10, 2021, as well as all new US office employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine.
Equal Employment OpportunityAt Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
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