The Role
Lead software testing initiatives for medical devices, ensuring quality through automation, compliance with FDA regulations, and collaboration across teams.
Summary Generated by Built In
Company Overview
Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
The Opportunity That Awaits You:
Are you ready to embark on an exciting journey that will revolutionize the way men suffering from BPH are treated? Join us as a Senior Software Test Engineer to ensure software quality within a complex medical device product through the development and execution of software test plan by way of verification procedure based upon software and system specifications.
What Your Day-To-Day Will Involve:
- 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.
- Collaborate with Program Management to maintain compliance with Design Controls and Risk Management procedures, and deliver complete Design History Files.
- 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.
- Support documentation reviews to ensure design safety, consistency, and compliance with regulatory standards such as FDA QSR.
- Log and track software issues through resolution while ensuring adherence to quality and regulatory expectations.
- Maintain compliance with PROCEPT BioRobotics’ Quality and EHS policies through active participation and training.
The Qualifications We Need You to Possess
- A Bachelor’s or Master’s degree in Engineering (or an equivalent technical field).
- 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.
- 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.
The Qualifications We Would Like You to Possess
- Experience with medical device testing or development.
- Experience with ISO 13485 and IEC 62304, and familiarity with FDA GMP.
Understanding PROCEPT's Culture
At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.
And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.
We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.
An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!
BENEFITS OF WORKING AT PROCEPT!
PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT
PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.
PAY RANGE TRANSPARENCY
Procept is committed to fair and equitable compensation practices. The pay range(s) for this role represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.
WORK ENVIRONMENT
We’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.
Top Skills
C
C#
C++
Git
Jama
Jenkins
JIRA
Python
Selenium
Squish
Winappdriver
Windows Os
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The Company
What We Do
PROCEPT BioRobotics is a commercial-stage surgical robotics company focused on advancing patient care by developing transformative solutions in urology. We develop, manufacture and sell the AQUABEAM Robotic System, an advanced, image-guided, surgical robotic system for use in minimally-invasive urologic surgery with an initial focus on treating benign prostatic hyperplasia, or BPH. Our proprietary AQUABEAM Robotic System delivers Aquablation therapy, which combines real-time, multidimensional imaging, personalized treatment planning, automated robotics and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. Aquablation therapy delivers effective, safe and durable outcomes for males suffering from lower urinary tract symptoms, or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience.
