Robotics & Digital Solutions, part of the Johnson & Johnson Family of companies, is recruiting for a Staff Quality Engineer, New Product Development (1 of 2), located in Santa Clara, CA!
Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon 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 robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer 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.
- Launch and stabilize new product launches through concept, design, development, and steady-state processes.
- Drives the development of product requirements, verification strategies, and validation strategies.
- Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards
- Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
- Proactively engage partners to drive consensus and resolve issues in a timely fashion.
- Provide statistical support and expertise and analytical problem solving for product development and manufacturing.
- Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures.
- Develop inspection and sampling plans, test methods, and transfer functions for products and components.
- Provide support and expertise in developing and executing a reliability strategy during new product development.
- Conducts projects and assignments with technical responsibility.
- Support the Risk Management Process per ISO 14971 and construction/maintenance of the Risk Management File.
- Participate in Design and Process FMEAs/FMECAs.
- Bachelor's Degree in Engineering from an accredited engineering school or related science field
- 6 years of quality experience
- New product development experience
- Experience in medical device industry or other highly regulated field
- Advanced knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of increasing complexity
- Previous work experience engaging in a team-based environment
- Ability to travel up to 25% domestic and international
- Advanced Degree
- Experience with medical electrical-mechanical systems
- Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment.
- 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)
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms
- Prior software quality engineering experience in a product development environment
United States-California-Santa Clara-
Auris Health, Inc. (6267)