Systems Quality and Reliability Lead
GroqSalary not specified
Full Time
Senior (5 to 8 years)
Senior Quality Engineer - Failure Analysis at PROCEPT BioRobotics
San Jose, California, United States
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Healthcare, RoboticsIndustries
Requirements
- BS degree in Engineering (Electrical or Mechanical Engineering Preferred) with 5+ years of experience or MS degree in Engineering and 3+ years of experience
- Experience of working in the Medical Device Industry
- Experience of performing Failure Analysis and root cause analysis
- Experience with data analysis and statistics
- Able to document technical investigations and communicate and defend technical investigations to upper management
- Able to effectively work with R&D and other cross functional teams to lead technical problem solving of trending failures in the field
- Strong ability to establish technical and professional credibility in a dynamic, fast-paced environment
- Understanding of risk management and CAPA process
- Experience with leading projects or process improvement initiatives with minimum supervision
Responsibilities
- Perform failure analysis testing on electromechanical devices and generate robust complaint investigation reports to comply to monthly closure metrics
- Lead a team of cross functional engineers to perform root cause analysis of critical device failures in the field
- Support development of methods and procedures for inspecting, testing and evaluating products
- Support the monthly complaint trending program
- Assist in Data Analysis to improve Failure Analysis Processes and product performance
- Evaluate all information from a technical perspective and perform appropriate investigation, root cause analysis, and quality engineering review as part of failure analysis process
- Participate in cross‐functional teams for quality improvement initiatives and continuous improvement
- Lead and Manage Projects related to improving team processes and product performance
- 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 EHS Policy
Skills
Failure Analysis
Root Cause Analysis
Electromechanical Devices
Complaint Investigation
Quality Engineering
Testing Methods
Inspection Procedures
Surgical Robotics
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