PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the company’s AquaBeam® Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics, and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size, or surgeon experience. 

SUMMARY
Are you interested in contributing to the reliability of PROCEPT BioRobotics products? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you detailed oriented? Imagine what you could do here. At PROCEPT BioRobotics you will be part of a team to work on a surgical robot that combines real time data, multi-dimensional imaging and robotics to remove prostate tissue. As PROCEPT BioRobotics continues to expand, the Design quality Assurance group requires a Senior Software Quality Test Engineer to support software testing. This person will be 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 (Other duties may be required as assigned)

• 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
• Perform software functional testing and integration testing
• Create and review test protocols and test reports for Graphical User Interface applications.
• Automate V&V tests using test frameworks and automation tools.
• Participate in risk management meeting to provide FMEA on software deliverables
• Create test tools that facilitate data gathering, post processing and test method execution
• Support clinical studies by validating data collection processes
• 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
• Support manufacturing by verifying fixture software or any software used during production
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
• Understand and adhere to the PROCEPT BioRobotics Quality Policy
• Understand and adhere to the PROCEPT BioRobotics EHS Policy

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
• 5 years of experience in software testing
• Experience with ISO 13485 and IEC 62304, and familiarity with FDA GMP
• Excellent written and verbal communication skills
• Ability to work as part of a multi-disciplinary team in a faced-paced company
• Strong interpersonal skills with ability to work both independently and as part of a team.
• Experience with software development for robotics, electromechanical systems, motion control
• Knowledge of C, C , C#, JAVA. GUI Design, OS: Windows strongly preferred
• Proficient in Python or other scripting language.
• Experience working on projects that follow Agile methodology.
• Experience developing test frameworks and automated test scripts.
• Experience with GUI automation tools (Squish, Selenium, WinApp Driver or equivalent) 
• Experience working with Test case management tools like JAMA.
• Experience working with management and defect tracking tools like Jira.
• Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to effectively present information and respond to questions from other internal groups, clients, customers, and the general public
• Ability to work with mathematical concepts
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

NICE TO HAVE

• Review test protocols for FPGA and microcontrollers.
• Experience with Cloud computing and cyber security.
• Experience with microcontroller, FPGA testing
• Experience with source control and development tools (GitHub or equivalent)
• Experience with continuous build and integration environments (Jenkins or equivalent)

PHYSICAL DEMANDS

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility. The employee may occasionally lift and/or move up to 15 pounds.
• Work Environment
• While performing the duties of this job, the employee regularly works in an office environment.
• COVID-I9 Vaccine Requirement: All PROCEPT BioRobotics employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical or religious exemptions.