Senior Quality Engineer - Disposables

PROCEPT BioRobotics•San Jose, CA

About The Position

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.

Requirements

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.

Nice To Haves

Knowledge of biocompatibility (ISO 10993) and biological risk assessment are a plus.
Knowledge of Reprocessing validations of reusable medical devices is a plus

Responsibilities

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.