Staff Quality Engineer, New Product Development, Surgical Robotics (1 of 2)

Ethicon, part of Johnson & Johnson Medical Devices Companies, is recruiting for , Staff Quality Engineer, New Product Development located in Redwood City, CA. Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopedics, endoluminal intervention and general surgery. This includes the MONARCH® platform, a first-of-its-kind robotic technology indicated for bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung. Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com. The Staff Quality Engineer, New Product Development will be responsible for providing quality engineering support and leadership for New Product Development. Responsibilities: Stabilize new product launches through steady-state processes. Drives the continuous improvement of product requirements, verification strategies, and validation strategies across design and manufacturing changes. Supports design and process changes throughout commercialization of product lives Ensures continued product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards Drive selection and challenge choice of critical customer requirements and system requirements; challenge requirements verifiability; challenge design output adequacy. Lead Critical to Quality flow throughout development cycle. Activities would drive prevention, detection of defects to improve/stabilize product launches, continuous improvement & customer satisfaction. Have functional product knowledge and ability to translate information into creating an executable test that stresses the system. Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical support, expertise and analytical problem solving for sustaining activities, including development and manufacturing. Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures. Leads investigations into non-conformances, driving consistencies in manufacturing processes and design Leads CAPA investigations and solution verification Conducts projects and assignments with technical responsibility. Supports the Risk Management process per ISO 14971 and construction / maintenance of the Risk Management File. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Qualifications Required: Good oral communication skills with the proven ability to convey complex information and provide solid recommendations. Bachelor’s Degree in Engineering from an accredited engineering school or related science field. 6 years of quality experience Knowledge of FDA requirements for design control of medical devices. Experience in medical device industry or other highly regulated field. Working knowledge of Quality Engineering / Scientific methods and techniques and applied statistics of increasing complexity. Previous work experience engaging in a team-based environment and ability to build relationships internally and externally. Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms. Demonstrated ability to articulate risk and make critical decisions regarding product quality or quality system compliance. Ability to travel up to 25% domestic and international. Preferred: Advanced Degree Understands and can apply reliability modeling to aid product design. Experience with medical electrical-mechanical systems ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) Primary Location United States-California-Redwood City-150 Shoreline Dr Organization Auris Health, Inc. (6267) Job Function Engineering Requisition ID 2105923622W