Company: Johnson & Johnson Location: Redwood City, CA Employment Type: Full Time Date Posted: 06/05/2021 Expire Date: 11/17/2021 Job Categories:
Computers, Software, Engineering, Healthcare, Practitioner and Technician, Information Technology, Manufacturing and Production, Military, Research & Development, Medical, Energy / Utilities
Staff Failure Analysis Engineer, Robotics
Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Staff Failure Analysis Engineer, Robotics, 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 orthopaedics, 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 Failure Analysis Engineer will be responsible for the hands-on technical analysis of sophisticated devices, components, hardware, and software to determine the root cause of failures or device issues. This is an individual contributor role for an inquisitive and driven team-player who will become intimately familiar with our medical devices and report out on findings to assist in the development of process and product improvements. The Staff Failure Analysis Engineer plays a meaningful role in the development and implementation of continuous improvement efforts within the organization.
Collaborate with Engineers, Suppliers, Clinical Specialists, Field Service Engineers and Manufacturing personnel to facilitate a deep understanding of device functionality and failures and to perform in depth root cause analysis.
Design and execute experiments and test methods to test theories to refine failure modes and determine root cause.
Acquire, analyze, and interpret information from data logs and various applications as well as perform physical (hands-on) deconstruction of devices as part of root cause analysis.
Utilize failure analysis laboratory equipment, such as: optical digital microscopes, probes, X-ray systems, custom electrical test software, data log applications, and other test equipment and fixtures in support of failure analysis.
Write formal analysis reports, resulting in clear and accurate messaging about analysis findings for a broad audience.
Provide frequent verbal and written updates of work-in-progress for various meetings.
Enhance investigation methodologies, develop and validate new test fixtures, and mentor the analysis team in the execution of those methods and tools.
Own CAPAs and drive product and process improvements.
Bachelor of Science degree in Mechanical Engineering, Electrical Engineering, Computer Science or related field
5 years of proven experience in a regulated environment (medical device, aerospace / defense, or similarly regulated industry)
Prior experience in a failure analysis role using failure analysis laboratory equipment, such as: optical digital microscopes, probes, X-ray systems, custom electrical test software, data log applications, and other test equipment and fixtures in support of failure analysis.
Sophisticated analytical and problem-solving skills
Confirmed ability to articulate risk and make critical decisions regarding product quality and quality system compliance.
Proficiency in root cause analysis tools and techniques (e.g. Hazard Analysis, FMEA, Fault Tree, Pareto diagrams, cause-and-effect diagrams, 5 whys, etc.)
Proven understanding and ability in the use of trend analysis, Pareto, and other basic charting techniques.
Outstanding communication, presentation and interpersonal skills working within all levels of the organization
Ability to work at both the Redwood City and Santa Clara, CA sites
Ability to travel up to 10%
Advanced Degree in Mechanical Engineering, Electrical Engineering, Computer Science or related field
Demonstrated technical knowledge across all aspects of robotics systems and/or software engineering.
Experience working with ISO 13485 and 14971, GMP guidelines, FDA regulations
Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor
Six-Sigma, ASQ CQE, or similar certifications
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-Redwood City-150 Shoreline Dr Organization Auris Health, Inc. (6267) Job Function Engineering Requisition ID 2105938826W