Ethicon's Robotic & Digital Solutions business is recruiting for a Quality Engineering Lead, 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
The Quality Engineering Leader, will be responsible for providing quality engineering support and leadership for New Product Development.
- The Quality Engineering Leader will lead a small team of direct reports potentially including engineers, technicians, and contractors.
- 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.
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.
- Bachelor's Degree in Engineering from an accredited engineering school or relevant science field
- 6 years experience working in the quality work field
- Experience in medical device industry
- Experience with medical electrical-mechanical systems
- New product development experience
- Advanced knowledge of Quality Engineering/Scientific methods and techniques
- Advanced knowledge of applied statistics of increasing complexity
- Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms
- Previous work experience engaging in a team-based environment
- Ability to travel up to 25% Moderate domestic and international
- Ability to work at the Redwood City, CA site
- Advanced Degree
- Prior supervisory experience
- 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).
- Prior software quality engineering experience in a product development environment.