PROCEPT BioRobotics is looking to revolutionize treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics, and needs to ensure the quality of their complex medical device software.
Requirements
- 8+ years of experience in software testing, with a strong foundation in automation.
- Hands-on experience developing test frameworks and automated test scripts.
- Proficiency in Python and C programming languages.
- Familiarity with GUI automation tools such as Squish, Selenium, or WinAppDriver.
- Experience using source control tools (e.g., GitHub) and continuous integration environments (e.g., Jenkins).
- Comfort working with test case management systems like JAMA and defect tracking tools like Jira.
- Working knowledge of C, C++, GUI design, and Windows OS is a strong plus.
Responsibilities
- Support new product development and design modifications, ensuring compliance with PROCEPT BioRobotics’ Quality Management System.
- Serve as a technical resource across software requirements, verification and validation, process validation, usability, statistical analysis, and risk management.
- Develop and implement quality and risk management plans to ensure product designs and processes consistently meet specifications and critical-to-quality standards.
- Lead software automation initiatives, including framework development, automated test scripting, and tool validation.
- Conduct and document software testing activities, including functional, integration, and automated test execution.
- Review design and software requirements for clarity, accuracy, and verifiability, and provide feedback during code and design reviews.
- Log and track software issues through resolution while ensuring adherence to quality and regulatory expectations.
Other
- A Bachelor’s or Master’s degree in Engineering (or an equivalent technical field).
- Experience collaborating in an Agile development environment.
- A solid understanding of medical device quality and regulatory standards, including 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
- Experience with medical device testing or development.
- Experience with ISO 13485 and IEC 62304, and familiarity with FDA GMP.
