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Senior Quality Engineer, Data Analytics

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
Do you want to be part of an innovative, cutting-edge technology, robotics company that is changing how BPH is treated? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you a leader who wants to make a difference and improve processes? Are you detailed-oriented? At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Regulatory Affairs and Quality Assurance department.
As a Senior Quality Engineer, Data Analytics you will report to the Director of Quality Systems and Post Market Surveillance and work with various functional teams to use your data analysis expertise, statistical skills, and understanding of Quality Management System processes to turn data into useful information. This position will be heavily involved with the creation, distribution, and successful delivery of reports on a periodic basis. The ideal candidate would have medical device post market experience and have the ability to explore and integrate different data sources using tools such as SQL and Tableau.


CORE RESPONSIBILITIES

  • Execute deep-dive analyses of available data to provide insight on product, operational, and service performance, including trend analysis and predictive forecasting and modeling.
  • Surface actionable insights from multiple sources to guide strategic initiatives and long-range planning.
  • Support cross-functional project-level verification testing activities, as needed, by providing statistical analysis and sound technical rationale for achieving adequate confidence intervals and reliability.
  • Identify areas to increase efficiencies and automate processes to remove repetitive steps in different areas of the Quality department and reduce human error.
  • Partner with Post Market Surveillance and Complaint Handling teams to satisfy field performance monitoring and reporting requirements.
  • Support functional, regression, usability test, etc. as applicable for both new and existing datasets, reports and dashboards to support Computer Software Assurance (CSA) program.
  • Translate non-technical data requirements into informative metrics and reports.
  • Develop user documentation to ensure consistency and accuracy of data analysis performance.
  • Perform ongoing improvements to legacy and new report and analytical solutions to ensure outstanding user experience
  • Perform ad-hoc data analysis and reporting upon request.
  • Participate and support internal and external audits, as needed.
  • 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 & EHS 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 Engineering with 7 years of data analytics experience, Master’s Degree with 5 years of data analytics experience.
  • Demonstrated success of converting data into actionable conclusions and driving change as a result.
  • Experience with Tableau and/or Microsoft SQL or equivalent strongly preferred.
  • Programming skills and experience, especially for data exploration and presentation to management and other users of data, is required.
  • Medical device, pharmaceutical, aerospace / defense, or other regulated industry experience strongly preferred.

PHYSICAL DEMANDS & WORK ENVIRONMENT

  • 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.
  • While performing the duties of this job, the employee regularly works in an office environment.
COVID-I9 Vaccine Requirement: As of August 19, 2021, all PROCEPT BioRobotics employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical or religious exemptions.
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CEO of Procept BioRobotics
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Reza Zadno
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Revolutionize BPH treatment globally in partnership with urologists by delivering best in class robotic solutions that positively impact patients and drive value.

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DATE POSTED
January 26, 2023

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