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

Company: Johnson & Johnson
Location: Santa Clara
Posted on: January 15, 2022

Job Description:

Ethicon, part of Johnson & Johnson Medical Devices Companies, is is recruiting for a Principal Quality Engineer, New Product Development , located in Santa Clara, 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 Principal Quality Engineer will be responsible for providing quality engineering support and leadership for New Product Development.

Responsibilities
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.
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.
Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, analysis of data, etc.

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.

Required

Qualifications
Bachelor's Degree in Engineering from an accredited engineering school or related science field
10 years of quality experience
New product development experience
Working knowledge of ISO 13485, ISO 14971(risk management), 21 CFR 820, IEC 60601-1 and/or MDD/MDR.
Experience in medical device industry
Advanced knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of increasing complexity
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
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)
Prior software quality engineering experience in a product development environment

Primary Location

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

Organization

Auris Health, Inc. (6267)

Job Function

Engineering

Requisition ID

2105956137W

Keywords: Johnson & Johnson, Santa Clara , Principal Quality Engineer, New Product Development, Surgical Robotics (1 of 2)., Engineering , Santa Clara, California

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