Senior Quality Engineer - Disposables at Procept Biorobotics

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:   Do you want to be part of an innovative, cutting-edge technology and robotics company that is transforming the treatment of BPH? Are you excited to work with an enthusiastic, driven, and collaborative team that continuously learns and improves together? Are you a leader who is passionate about driving process excellence and making a meaningful impact? Are you detail-oriented and thrive in a fast-paced NPI environment? At PROCEPT BioRobotics, you will have the opportunity to contribute to our continuous improvement culture as part of our Quality Engineering team, supporting New Product Introduction (NPI) for Disposables and Accessories. As a Senior Quality Engineer, you will play a critical role in ensuring the quality, reliability, and scalability of our single-use products and accessory components from development through commercialization. In this role, you will partner cross-functionally with R&D, Manufacturing, Regulatory and Supply Chain teams to support product development, design transfer, and production readiness. You will help establish and maintain robust quality systems and processes in compliance with FDA Quality System Regulation (QSR), ISO 13485, and EU MDR. A detail-oriented, proactive, and solutions-driven mindset, along with the ability to independently manage priorities in a dynamic NPI environment, will be key to success in this position. What Your Day-To-Day Will Involve: • Lead and contribute to the planning and execution of design controls, risk management, and design verification/validation (V&V) for new products. • Develop, maintain, and support the Design History File (DHF), ensuring complete compliance with internal Quality Management System (QMS) processes and external regulatory standards. • Partner closely with R&D engineering to clearly define design inputs, design outputs, and comprehensive traceability matrices. • Drive the strategy and execution of risk-based design verification and validation testing. • Spearhead the development of the Risk Management File (per ISO 14971), analyzing and assessing risks associated with the user, design, manufacturing process, and supply chain. • Ensure that robust, reliable, and scalable designs are successfully transferred to manufacturing environments. Review early-stage designs, material selections, technical requirements, and engineering drawings for manufacturability and quality. • Evaluate and assess Verification & Validation (V&V) failures, perform root cause analysis, and drive Non conformances (NCMRs), corrective and preventive actions (CAPA) to ensure product quality and compliance • Collaborate with Regulatory Affairs to provide vital technical data and documentation for regulatory submissions (e.g., 510(k), MDR) and actively respond to agency submission questions. • Support internal and external audits including preparation and direct interaction with auditors. • Demonstrates knowledge of biocompatibility, sterilization methods (EO, VHP), atmospheric conditioning, and transit testing, with the ability to perform change assessments • Knowledge of reprocessing reusable medical devices is a plus. • Maintain trained status for and comply with all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. • Ability to support/lead department projects and perform other work-related duties as assigned The Qualifications We Need You to Possess • BS in Engineering, Microbiology, Life Sciences, or related technical field (MS preferred) • Minimum 5+ years of experience in medical device industry (class II medical devices preferred) • Direct experience working with surgical instruments, electromechanical devices, or surgical accessories is highly preferred. • Strong understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR. • Self-starter with ability to lead in a fast-paced environment with ability to prioritize and manage multiple projects. • Proficient in statistical methods and tools such as Minitab to support validation and quality decisions. • Strong leadership in initiating improvement discussions and driving team success. The Qualifications We Would Like You to Possess • Knowledge of biocompatibility (ISO 10993) and biological risk assessment are a plus. • Knowledge of Reprocessing validations of reusable medical devices is a plus For US-Based Candidates Only Work Authorization Status: Citizen / Permanent Resident   For this role, the anticipated base pay range is $126,820--149,000 per year. Plus, eligibility for an annual bonus and equity/RSUs 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, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.   And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.   We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.   An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!   BENEFITS OF WORKING AT PROCEPT!  PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan 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 many more! EQUAL EMPLOYMENT OPPORTUNITY 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 set forth in 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. The pay range(s) for this role represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.   WORK ENVIRONMENT We’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies. PROCEPT BioRobotics – Applicant Privacy Notice When you submit an application on this site, PROCEPT BioRobotics collects the personal information you provide. This may include your name, email address, phone number, résumé or CV, LinkedIn profile, and any optional demographic information you choose to share, such as gender or ethnicity. We use this information to review your application and assess your suitability for the role.   To learn more about how we handle personal information, including your rights under applicable privacy regulations, please read our full Privacy Notice at: [Privacy Policy].