Medium
Quality Engineer - NPI - Disposables and Accessories
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 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, also 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, and create an evolving landscape for your career with transformative opportunities and continuous 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. Responsibilities
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. $100,000 - $118,000 a year Compensation also includes a yearly 10% bonus and RSUs at offer! Culture and Benefits
Understanding PROCEPT's Culture At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, we believe in innovating with pathological optimism. We value humility, engagement, and cross-functional collaboration to achieve a common goal. Curiosity, ingenuity, and conviction in the power of technology will transform the lives of our patients and providers. We begin with a live induction program that introduces cross-functional team building, PROCEPT’s history, executive leadership, and the mission and purpose of our work. We also offer a management program designed to develop managers across functions to exchange ideas and grow in an environment that challenges, supports, and broadens. We are driven by the opportunity to give people their lives back and strive for a work/life blend in a professional environment you are proud to share with your family, friends, and colleagues. An opportunity at PROCEPT BioRobotics won’t just be a job; it will be a chance to join a community devoted to making a difference. Benefits and Compliance
Benefits of Working at PROCEPT PROCEPT offers health and wellness benefits for employees, including full medical coverage, wellness programs, on-site gym, 401(k) with employer match, short-term and long-term disability coverage, 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 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 federal, state, or local laws. This policy applies to all employment practices within our organization. PAY RANGE TRANSPARENCY PROCEPT is committed to fair and equitable compensation practices. Pay ranges for this role represent base salary ranges or on-target earnings for commissionable roles. Actual compensation is based on factors such as job-related skills, experience, certifications, and location. The total package may include annual performance bonus, equity, and the benefits listed above. WORK ENVIRONMENT We provide training to maintain status for and compliance with the PROCEPT BioRobotics Quality Management System and require understanding and adherence to the 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 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, also 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, and create an evolving landscape for your career with transformative opportunities and continuous 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. Responsibilities
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. $100,000 - $118,000 a year Compensation also includes a yearly 10% bonus and RSUs at offer! Culture and Benefits
Understanding PROCEPT's Culture At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, we believe in innovating with pathological optimism. We value humility, engagement, and cross-functional collaboration to achieve a common goal. Curiosity, ingenuity, and conviction in the power of technology will transform the lives of our patients and providers. We begin with a live induction program that introduces cross-functional team building, PROCEPT’s history, executive leadership, and the mission and purpose of our work. We also offer a management program designed to develop managers across functions to exchange ideas and grow in an environment that challenges, supports, and broadens. We are driven by the opportunity to give people their lives back and strive for a work/life blend in a professional environment you are proud to share with your family, friends, and colleagues. An opportunity at PROCEPT BioRobotics won’t just be a job; it will be a chance to join a community devoted to making a difference. Benefits and Compliance
Benefits of Working at PROCEPT PROCEPT offers health and wellness benefits for employees, including full medical coverage, wellness programs, on-site gym, 401(k) with employer match, short-term and long-term disability coverage, 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 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 federal, state, or local laws. This policy applies to all employment practices within our organization. PAY RANGE TRANSPARENCY PROCEPT is committed to fair and equitable compensation practices. Pay ranges for this role represent base salary ranges or on-target earnings for commissionable roles. Actual compensation is based on factors such as job-related skills, experience, certifications, and location. The total package may include annual performance bonus, equity, and the benefits listed above. WORK ENVIRONMENT We provide training to maintain status for and compliance with the PROCEPT BioRobotics Quality Management System and require understanding and adherence to the Quality & EHS policies.
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