PROCEPT BioRobotics
Quality Engineer - NPI - Disposables and Accessories
PROCEPT BioRobotics, San Jose, California, United States, 95199
Quality Engineer - NPI - Disposables and Accessories
This range is provided by PROCEPT BioRobotics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $100,000.00/yr - $118,000.00/yr Overview
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 : Quality Engineer plays a critical role in supporting the design and development of innovative surgical robotics technologies, ensuring compliance with PROCEPT BioRobotics’ Quality Management System and applicable regulatory requirements. This role collaborates cross-functionally with Engineering, Program Management, and Regulatory teams to ensure robust product development, risk management, and design control practices are followed throughout the product lifecycle. What Your Day-To-Day Will Involve
Contribute to design modifications for existing disposables and accessory products to ensure alignment with PROCEPT’s Quality System Support risk management activities, including updating risk documentation and gathering risk data for monthly and quarterly reviews Act as a technical resource across requirements development, risk analysis, verification and validation (V&V), and design transfer processes Provide engineering support to PROCEPT-BioRobotics’ design and development efforts, with a primary focus on biocompatibility, sterilization, and stability testing Collaborate closely with third-party test laboratories to ensure the accuracy and completeness of all submitted information for final reports Assist Program Management in ensuring adherence to Design Control and Risk Management procedures and in the creation of Design History Files (DHFs) Support the implementation of master verification and validation plans, as well as own risk management plans, to ensure that product designs and processes consistently meet specifications and critical-to-quality attributes Collaborate with the QA department during quality audits, including those conducted by the FDA and Notified Bodies, and assist in addressing non-conformances Participate in corrective and preventive actions (CAPA) related to product design and quality assurance 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
Bachelor’s degree in mechanical engineering, biomedical engineering, or related discipline 1-2 years of experience in a design quality, product development, or medical device environment Working knowledge of FDA regulation (21 CFR Part 820), MDSAP and international standards such as ISO 13485, ISO 14971, ISO 11607, ISO 10993 and ISO 11135 Strong understanding of design control processes, risk management, and quality assurance in medical devices Experience with verification and validation planning, execution, and documentation Excellent communication, organizational, and problem-solving skills Ability to work effectively in a cross-functional environment Culture, Benefits & Compliance
Understanding PROCEPT's Culture At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. We are driven to revolutionize care with curiosity, humility, engagement, and collaboration, focused on transforming lives through technology. Benefits PROCEPT’s health and wellness benefits for employees include full medical coverage, wellness programs, on-site gym, 401(k) with employer match, disability coverage, life insurance, wellbeing benefits, paid time off, paid parental leave, paid holidays, and more. EEO 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 under applicable laws. Pay Transparency We are committed to fair and equitable compensation practices. The pay range represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation depends on factors including skills, experience, certifications, and location. The total package may include annual bonus potential, equity, and the listed benefits. Work Environment We provide training and expect you to maintain status for and comply with all relevant aspects of the Quality Management System and related policies. Compensation may include a yearly 10% bonus and RSUs at offer. Role Details
Seniority level: Not Applicable Employment type: Full-time Job function: Quality Assurance Industry: Medical Equipment Manufacturing
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This range is provided by PROCEPT BioRobotics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $100,000.00/yr - $118,000.00/yr Overview
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 : Quality Engineer plays a critical role in supporting the design and development of innovative surgical robotics technologies, ensuring compliance with PROCEPT BioRobotics’ Quality Management System and applicable regulatory requirements. This role collaborates cross-functionally with Engineering, Program Management, and Regulatory teams to ensure robust product development, risk management, and design control practices are followed throughout the product lifecycle. What Your Day-To-Day Will Involve
Contribute to design modifications for existing disposables and accessory products to ensure alignment with PROCEPT’s Quality System Support risk management activities, including updating risk documentation and gathering risk data for monthly and quarterly reviews Act as a technical resource across requirements development, risk analysis, verification and validation (V&V), and design transfer processes Provide engineering support to PROCEPT-BioRobotics’ design and development efforts, with a primary focus on biocompatibility, sterilization, and stability testing Collaborate closely with third-party test laboratories to ensure the accuracy and completeness of all submitted information for final reports Assist Program Management in ensuring adherence to Design Control and Risk Management procedures and in the creation of Design History Files (DHFs) Support the implementation of master verification and validation plans, as well as own risk management plans, to ensure that product designs and processes consistently meet specifications and critical-to-quality attributes Collaborate with the QA department during quality audits, including those conducted by the FDA and Notified Bodies, and assist in addressing non-conformances Participate in corrective and preventive actions (CAPA) related to product design and quality assurance 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
Bachelor’s degree in mechanical engineering, biomedical engineering, or related discipline 1-2 years of experience in a design quality, product development, or medical device environment Working knowledge of FDA regulation (21 CFR Part 820), MDSAP and international standards such as ISO 13485, ISO 14971, ISO 11607, ISO 10993 and ISO 11135 Strong understanding of design control processes, risk management, and quality assurance in medical devices Experience with verification and validation planning, execution, and documentation Excellent communication, organizational, and problem-solving skills Ability to work effectively in a cross-functional environment Culture, Benefits & Compliance
Understanding PROCEPT's Culture At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. We are driven to revolutionize care with curiosity, humility, engagement, and collaboration, focused on transforming lives through technology. Benefits PROCEPT’s health and wellness benefits for employees include full medical coverage, wellness programs, on-site gym, 401(k) with employer match, disability coverage, life insurance, wellbeing benefits, paid time off, paid parental leave, paid holidays, and more. EEO 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 under applicable laws. Pay Transparency We are committed to fair and equitable compensation practices. The pay range represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation depends on factors including skills, experience, certifications, and location. The total package may include annual bonus potential, equity, and the listed benefits. Work Environment We provide training and expect you to maintain status for and comply with all relevant aspects of the Quality Management System and related policies. Compensation may include a yearly 10% bonus and RSUs at offer. Role Details
Seniority level: Not Applicable Employment type: Full-time Job function: Quality Assurance Industry: Medical Equipment Manufacturing
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