Quality Engineer - NPI - Disposables and Accessories

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We 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

The Qualifications We Need You to Possess:

• Bachelor’s degree in mechanical engineering, biomedical engineering, or related discipline.
• 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.

Understanding PROCEPT's CultureAt 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/li