Job Description:
· Responsible for ensuring software quality within complex medical device products through the
· development and execution of software test plans by way of verification procedures based upon
· software and system specifications.
Core Responsibilities
· Support new product development and design changes to existing products in ensuring compliance with company’s Quality System
· Perform software functional testing and integration testing
· Develop automation test frameworks and automation test scripts.
· Create and review test protocols and test reports for Graphical User Interface applications.
· Create test tools that facilitate data gathering, post processing and test method execution.
· Develop manual software test protocols.
· Review product design requirements and software requirements to ensure that requirements stated are correct, unambiguous, and verifiable.
· Consult with product development to evaluate system interfaces, operational requirements, and performance requirements of overall system.
· Assist in product design documentation reviews for safety, consistency, traceability, and compliance to regulations (such as the FDA QSR design control requirements).
· Log software issues and track progress of bug fixes.
· Perform software tool validations.
· Maintain trained status for, and comply with, all relevant aspects of the PROCEP
· BioRobotics Quality .Management System to ensure product and support regulatory compliance.
· Understand and adhere to the PROCEPT BioRobotics Quality & EHR Policies.
QUALIFICATIONS (Education, Experience, Certifications
· To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
· Bachelor’s Degree in Computer Science, Computer Engineering, or equivalent technical Degree; or equivalent combination of education and/or experience.
· Experience with medical device testing or development.
· 5-7 years of experience in desktop automation testing.
· Experience with GUI automation tools (Squish, Selenium, WinApp Driver or equivalent).
· Experience developing test frameworks using Python.
· Experience working with Test case management tools like JAMA.
· Experience working with management and defect tracking tools like Jira.
· Knowledge of C, C++, GUI Design, OS: Windows strongly preferred.
· Ability to work as part of a multi-disciplinary team in a faced-paced company.
· Experience working on projects that follow Agile methodology.
Nice to have:
· Experience with machine learning and cyber security.
· Experience with ISO 13485 and IEC 62304, and familiarity with FDA GMP.
· Experience with software development for robotics, electromechanical systems, motion
· control.
Any Graduate