Staff Software Test Engineer at PROCEPT BioRobotics

San Jose, California, United States

PROCEPT BioRobotics Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Surgical Robotics, HealthcareIndustries

Requirements

  • 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
  • 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
  • Working knowledge of C, C++, GUI design, and Windows OS (strong plus)
  • Experience with medical device testing or development (preferred)
  • Experience with ISO 13485 and IEC 62304, and familiarity with FDA GMP (preferred)

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
  • 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

Skills

Software Testing
Verification
Validation
Test Automation
Automated Test Scripting
Risk Management
Design Controls
Quality Management System
Statistical Analysis
Process Validation
Usability Testing

PROCEPT BioRobotics

Develops robotic solutions for BPH treatment

About PROCEPT BioRobotics

PROCEPT BioRobotics develops robotic solutions specifically for treating benign prostatic hyperplasia (BPH), a condition that affects many older men by causing prostate enlargement and urinary issues. Their main product, the AquaBeam Robotic System, utilizes Aquablation therapy, which combines real-time imaging, robotics, and waterjet technology to precisely remove prostate tissue in a minimally invasive manner. This system is designed for urologists and healthcare facilities, focusing on enhancing patient outcomes and making surgical procedures more efficient. Unlike competitors, PROCEPT BioRobotics emphasizes predictable results and reduced complications, which has led to their technology being recognized in clinical guidelines. The company's goal is to improve the quality of life for patients suffering from BPH through advanced surgical solutions.

Redwood City, CaliforniaHeadquarters
2009Year Founded
$319.1MTotal Funding
IPOCompany Stage
Robotics & Automation, HealthcareIndustries
501-1,000Employees

Benefits

Health Insurance
401(k) Company Match
401(k) Retirement Plan
Paid Vacation
Paid Parental Leave
Paid Holidays
Wellness Program
Gym Membership

Risks

Competition from Intuitive Surgical and Medtronic may impact market share.
$175 million public stock offering could lead to shareholder dilution.
Reliance on AquaBeam System makes company vulnerable to technological failures.

Differentiation

AquaBeam Robotic System offers image-guided, minimally invasive urologic surgery.
Aquablation therapy provides effective outcomes regardless of prostate size or surgeon experience.
PROCEPT has over 100 peer-reviewed publications supporting Aquablation therapy's benefits.

Upsides

Increasing adoption of robotic-assisted surgeries boosts demand for AquaBeam System.
Global urology devices market projected to grow at 6.9% CAGR until 2030.
FDA's supportive regulatory environment favors innovative medical technologies like PROCEPT's.

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