The Software Quality (SWQA) Manger will have software quality and quality systems compliance responsibilities for Medical Device Data Systems (MDDS) and Medical Device Mobile Applications (Class 1 Devices) in IOT and Development (Dev) Ops environment. The vision of the SWQA Organization is to be an accountable and trusted partner to R&D, Marketing, and Regulatory that accelerates innovation through effective, compliant, and efficient processes to deliver the highest quality products and systems to improve the lives of our patients.
The candidate will provide software quality support and drive validation strategies for business units developing Medical Mobile Apps, Medical Device Data Systems (MDDS), Machine Learning and Artificial Intelligence solutions within an IoT and Dev Ops platform.
The position will provide opportunities for advancement within our growing organization. We are looking for an ambitious candidate with strong technical and communication skills, including the capability to build trusting relationships and partnerships across the organization.
Responsibilities for this position includes:
* Building and growing a new functional area in SWQA to help deliver emerging technologies in Artificial Intelligence and Machine Learning in an IoT connected environment
* Providing technical leadership and software quality engineering support on MDDS and Software Medical Mobile Apps related projects
* Providing software quality support and drive validation strategies for business units developing Medical Mobile Apps, Medical Device Data Systems (MDDS), Machine Learning and Artificial Intelligence solutions within an IoT and Dev Ops platform
* Creating and executing risk management activities to support software product(s)
* Establishing and implementing quality system processes to support Medical Device Software Solutions (Class 1 and IIa), MDDS and Dev Ops
* Ensuring Software Verification and Validation activities adhere to business processes and procedures
* Leading Software Change Board and Code Review meetings to address software issues and track change control activities
* Managing software defects and problem reports
Building trusting relationships with R&D, Regulatory, Marketing, IT, and Quality personnel to ensure software is state of art and maintained in a state of compliance to support business operations
* Effectively managing priorities in a dynamic environment
* Effectively communicating ideas, issues, and project status to upper management
* Fostering a spirit of teamwork that allows for open discussion and exploration of diverse ideas; builds an environment of trust, transparency, and cohesiveness.
WORK EXPERIENCE REQUIREMENTS
Technical and professional competencies for this position are as follows:
* Must have a Bachelor's degree in Sciences or Engineering with 10 years of work experience or a Master's degree with 7 years of work experience in Medical Device Software Quality, Software V&V or Software Development
* Excellent written and verbal communication skills required
* Highly detailed and technical, interpersonal skills and ability to defend quality assurance is required
* Experience in Medical Device Software Quality, V&V or Software Development within an IoT connected platform is required (Microsoft Azure preferred)
* Experience with MDDS is preferred
* Experience with software algorithms development and machine learning is preferred
* Working experience in automated SDLC systems (ALM or PLM) is preferred.
About Edwards Lifesciences
Edwards Lifesciences is an American medical equipment company specializing in artificial heart valves and hemodynamic monitoring.