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.
Primary Function:
· System software verification and validation of radiology device products to meet FDA design controls
POSITION DUTIES & RESPONSIBILITIES
Activities
· Verification and Validation of software for complex system interactions in medical devices, including
• Embedded software
• Platform software
• Operating system software
· Development and execution of manual and/or automated software verification protocols, including:
• Design and development of test scenarios
• Authoring and review of test cases and protocols
• Performing execution of test cases
• Writing reports
· Responsible for verification of the software platform of the medical device, including:
• Sub-system testing
• Performance and reliability
• Safety and interoperability
· Review and analysis of product and software requirements
· Defect characterization and reporting. Assist in triaging of the defects.
· 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
Skill & Competency Requirements:
· Bachelor’s degree in engineering, preferably Computer, Electronics, or Biomedical
· Minimum of 2 years of relevant work experience in software testing in medical device or in a regulated industry
· Minimum of 1 years of relevant work experience in software test automation
· Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodologies
- Familiarity with C/C++, Python languages and test frameworks.
- Understands impacts of hardware constraints on software environment.
- Familiarity with ST microprocessor, FPGA, BLDC, peripheral device communication and embedded RTOS
Technical writing ability – clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.)
· Have a strong sense of ownership and project outcome.
· This position requires the candidate to work from office
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, GoogleTest, JIRA, Artifactory, 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
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