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J&J Family of Companies Quality Manager, New Product Development Engineering, Surgical Robotics in Santa Clara, California

Johnson & Johnson's Family of Companies is recruiting for a Quality Manager, New Product Development Engineering, Surgical Robotics, within our Robotics & Digital Solutions organization. The location for this position is Santa Clara, CA!

Robotics and Digital Solutions, is part of Johnson & Johnson Med Tech. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), Cincinnati, and Seattle. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes.

The Manager will be responsible for providing quality engineering support and leadership for New Product Development.

Responsibilities:

  • The Quality Engineering Manager/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.

Qualifications

Required:

  • Bachelor’s Degree in Engineering or relevant science field

  • 6 years’ experience working in the quality work field

  • Experience in medical device industry

  • Experience with medical electrical-mechanical & hardware systems

  • New product development experience

  • Prior leadership 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% domestic and international

  • Ability to work at the Santa Clara, CA site

Preferred:

  • Advanced Degree

  • Inspection techniques and GD&T 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

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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.

Primary Location

United States-California-Santa Clara-5490 Great America Pkwy

Organization

Auris Health, Inc. (6267)

Job Function

Engineering

Requisition ID

2206078343W

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