Primary Function: System software verification and validation of radiology device products to meet FDA design controls
Position Summary:
This position will be responsible to perform software verification and validation of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.
Position Duties and Responsibilities:
Verification and Validation of software for complex system interactions in medical devices, including:
Application software
Embedded software
Platform software
Operating system software
Development and execution of manual and/or automated software verification protocols, including:
Requirement analysis and review
Architect test strategy
Design and development of test scenarios
Authoring, Review and execution of test cases and protocols
Authoring, Review and execution of automated test scripts
Analyzing results, tracking discrepancies, and writing reports
Responsible for verification of the software platform of the medical device, including:
User interface and interactions
Performance and reliability
Safety and interoperability
Compliance with standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304
Critical analysis of technical situations, identifies problems, and work with the cross-functional team in resolving the problems.
Collaborating within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in medical device R&D activities
Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function
Requirements/Preferences:
Skills & Competency Requirements:
Bachelor's degree in Engineering, preferably Computer, Electronics, Electrical
Minimum of 5 years or more experience in automated test script development and execution
Experience with python programing / scripting is a must
Experience with Automation framework development.
Technical writing ability - clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.)
Ability to work in-office all days of the week
Preferences:
Experience designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485 and IEC 62304
Working knowledge of tools such as Rational Quality Manager, Jenkins, Squish, TOSCA, JIRA, Git and DOORS Next Gen
Working knowledge on OS such as Windows, Linux flavors
Demonstrated ability working in a matrix/hybrid organization structure
Ability to troubleshoot and make quick knowledge and experience-guided decisions
Excellent written and oral communication
Excellent people skills, ability to partner well, good team camaraderie
Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools