Software Testing Specialist

6 days ago

pittsburgh, United States Envision Full time

No C2C, No Sponsorship


Must reside in Pittsburgh area.


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 & RESPONSIBILITIES

Activities

• Verification and Validation of software for complex system interactions in medical devices, including

o Application software

o Embedded software

o Platform software

o Operating system software

• Development and execution of manual and/or automated software verification protocols, including:

o Requirement analysis and review

o Architect test strategy

o Design and development of test scenarios

o Authoring, Review and execution of test cases and protocols

o Authoring, Review and execution of automated test scripts

o Analyzing results, tracking discrepancies, and writing reports

• Responsible for verification of the software platform of the medical device, including:

o User interface and interactions

o Performance and reliability

o 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

Skill & 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

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