PROCEPT BioRobotics
Quality Engineer - NPI - Disposables and Accessories
PROCEPT BioRobotics, 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. At PROCEPT, we put the patient first and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics. As our company grows, we strive to improve the quality of life for patients and provide more effective treatment options for surgeons, while upholding the trust of our shareholders. We focus on our People and offer opportunities for career growth. 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 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 product designs and processes 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 regulatory compliance. Understand and adhere to the PROCEPT BioRobotics Quality & EHS policies. The Qualifications We Need You to Possess
Bachelor’s degree in mechanical engineering, biomedical engineering, or a related discipline. 1–2 years of experience in design quality, product development, or a 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. Compensation
$100,000 - $118,000 a year. Compensation also includes a yearly 10% bonus and RSUs at offer. Understanding PROCEPT's Culture
At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. We are committed to innovation with a patient-first mindset and a collaborative culture that supports growth and learning. Benefits & Equal Opportunity
Benefits : PROCEPT health and wellness benefits, full medical coverage, wellness programs, on-site gym, 401(k) with employer match, disability coverage, life insurance, 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 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 Range Transparency
Procept is 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 is based on factors including skills, experience, certifications, and location, and may include eligibility for annual performance bonus, equity, and the listed benefits. Work Environment
We provide training to maintain status for and comply with all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and regulatory compliance. Employees are expected to understand and adhere to PROCEPT’s Quality & EHS policies.
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Company Overview Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do. At PROCEPT, we put the patient first and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics. As our company grows, we strive to improve the quality of life for patients and provide more effective treatment options for surgeons, while upholding the trust of our shareholders. We focus on our People and offer opportunities for career growth. 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 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 product designs and processes 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 regulatory compliance. Understand and adhere to the PROCEPT BioRobotics Quality & EHS policies. The Qualifications We Need You to Possess
Bachelor’s degree in mechanical engineering, biomedical engineering, or a related discipline. 1–2 years of experience in design quality, product development, or a 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. Compensation
$100,000 - $118,000 a year. Compensation also includes a yearly 10% bonus and RSUs at offer. Understanding PROCEPT's Culture
At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. We are committed to innovation with a patient-first mindset and a collaborative culture that supports growth and learning. Benefits & Equal Opportunity
Benefits : PROCEPT health and wellness benefits, full medical coverage, wellness programs, on-site gym, 401(k) with employer match, disability coverage, life insurance, 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 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 Range Transparency
Procept is 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 is based on factors including skills, experience, certifications, and location, and may include eligibility for annual performance bonus, equity, and the listed benefits. Work Environment
We provide training to maintain status for and comply with all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and regulatory compliance. Employees are expected to understand and adhere to PROCEPT’s Quality & EHS policies.
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