Medium
Senior Quality Engineer - Failure Analysis
Medium, San Jose, California, United States, 95199
Overview
Company Overview: Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do. We put the patient first and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics. We focus on creating an evolving landscape for your career with transformative opportunities and continuous growth. The Opportunity That Awaits You
Senior Quality Engineer - Failure Analysis. Join us to investigate failures of the Robotic System that delivers Aquablation. Your mission is to identify root causes of product failures seen in the field and provide input to design teams to safeguard patient safety and improve customer experience by improving product performance. You will bridge field staff and internal design teams, helping to transform lives and shape the future of healthcare. What Your Day-To-Day Will Involve
Perform failure analysis testing on electromechanical devices and generate robust complaint investigation reports to comply with 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 information from a technical perspective and perform investigation, root cause analysis, and quality engineering review as part of the 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 regulatory compliance. Understand and adhere to the PROCEPT BioRobotics EHS Policy. The Qualifications We Need You to Possess
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 in the Medical Device Industry. Experience 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 work with R&D and 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 leading projects or process improvement initiatives with minimum supervision. The Qualifications We Would Like You to Possess
Product development experience. Able to influence cross-functional teams and development teams to improve processes and design based on field findings. Compensation and Benefits
$130,000 - $154,000 a year. This position also includes an annual bonus of 15%, RSUs at offer, and flexible time off. For US-Based Candidates Only
Work Authorization Status: Citizen / Permanent Resident Understanding PROCEPT's Culture
At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. We are committed to innovation with optimism and humility, and we value curiosity, ingenuity, and conviction in the power technology to transform lives. We offer a live induction program for cross-functional team building, an immersion in Procept’s history, executive leadership sessions, and a management program to build capable managers. Our goal is to create an environment where people can grow as both managers and learners. We aim to give people their lives back by pursuing a work/life blend in a professional community you can be proud to belong to. Benefits and Workplace Information
BENEFITS OF WORKING AT PROCEPT : Health and wellness benefits, full medical coverage, wellness programs, on-site gym, 401(k) with employer match, short- and long-term disability, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and more. EQUAL EMPLOYMENT OPPORTUNITY STATEMENT PROCEPT BioRobotics is an equal opportunity employer committed to diversity and inclusion. We prohibit discrimination and harassment based on race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status under law. This policy applies to all employment practices. PAY RANGE TRANSPARENCY Pay ranges represent base salary for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation is based on factors including skills, experience, certifications, and location. Total compensation may include bonus, equity, and listed benefits. Work Environment
We provide training to maintain status for and ensure compliance with the PROCEPT BioRobotics Quality Management System and Quality & EHS policies.
#J-18808-Ljbffr
Company Overview: Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do. We put the patient first and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics. We focus on creating an evolving landscape for your career with transformative opportunities and continuous growth. The Opportunity That Awaits You
Senior Quality Engineer - Failure Analysis. Join us to investigate failures of the Robotic System that delivers Aquablation. Your mission is to identify root causes of product failures seen in the field and provide input to design teams to safeguard patient safety and improve customer experience by improving product performance. You will bridge field staff and internal design teams, helping to transform lives and shape the future of healthcare. What Your Day-To-Day Will Involve
Perform failure analysis testing on electromechanical devices and generate robust complaint investigation reports to comply with 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 information from a technical perspective and perform investigation, root cause analysis, and quality engineering review as part of the 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 regulatory compliance. Understand and adhere to the PROCEPT BioRobotics EHS Policy. The Qualifications We Need You to Possess
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 in the Medical Device Industry. Experience 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 work with R&D and 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 leading projects or process improvement initiatives with minimum supervision. The Qualifications We Would Like You to Possess
Product development experience. Able to influence cross-functional teams and development teams to improve processes and design based on field findings. Compensation and Benefits
$130,000 - $154,000 a year. This position also includes an annual bonus of 15%, RSUs at offer, and flexible time off. For US-Based Candidates Only
Work Authorization Status: Citizen / Permanent Resident Understanding PROCEPT's Culture
At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. We are committed to innovation with optimism and humility, and we value curiosity, ingenuity, and conviction in the power technology to transform lives. We offer a live induction program for cross-functional team building, an immersion in Procept’s history, executive leadership sessions, and a management program to build capable managers. Our goal is to create an environment where people can grow as both managers and learners. We aim to give people their lives back by pursuing a work/life blend in a professional community you can be proud to belong to. Benefits and Workplace Information
BENEFITS OF WORKING AT PROCEPT : Health and wellness benefits, full medical coverage, wellness programs, on-site gym, 401(k) with employer match, short- and long-term disability, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and more. EQUAL EMPLOYMENT OPPORTUNITY STATEMENT PROCEPT BioRobotics is an equal opportunity employer committed to diversity and inclusion. We prohibit discrimination and harassment based on race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status under law. This policy applies to all employment practices. PAY RANGE TRANSPARENCY Pay ranges represent base salary for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation is based on factors including skills, experience, certifications, and location. Total compensation may include bonus, equity, and listed benefits. Work Environment
We provide training to maintain status for and ensure compliance with the PROCEPT BioRobotics Quality Management System and Quality & EHS policies.
#J-18808-Ljbffr