Software Lifecycle Project Manager

Requirements:• Minimum 2 years in managing software development projects or related experience• At least 2 years’ experience working in a medical device software / highly regulated environment• Degree in Software Engineering or experience in software development a plus• Understanding of product-driven development needs and the downstream effects to technical documentation and testing.• Familiar with general UI expectations and conventions.• Able to translate user needs into testable specifications• Understanding of regulatory requirements for design controls, software development, and evidence to support design, verification, validation, and release activities.• Experience creating, managing, reporting and maintaining unique device identifiers (UDIs) for software devices in the USA (international experience a plus).• Demonstrated experience evaluating field reports, complaints, and post-market feedback to identify reportable events and triage of software maintenance and improvement.• Understanding of regulatory terminology (e.g., intended use, indications for use), submission types for marketing authorization in the USA, and the impact of software changes as they relate to marketing submissions.