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J&J Family of Companies Clinical Engineer (1 of 3) in Santa Clara, California

Ethicon, part of Johnson & Johnson Medical Devices Companies, is recruiting for a Clinical Engineer (1 of 2), 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 (https://protect-us.mimecast.com/s/JaDLCkRg2ki5NlORTVNkS-?domain=ethicon.com) .

Clinical Engineers at Ethicon work closely with physicians, clinicians, engineers, and collaborate across quality, regulatory, and marketing. We work in the field with top physicians, understanding their needs, issues and challenges. We also work with internal engineering development teams as the active Voice of the Surgeon to help drive the surgeon and patient experience of the devices we design.

Clinical Engineering is a key "connection" between engineering/product development, and physicians and clinicians who perform the procedures and the workflow in the OR. As a member of the Clinical Innovation team, the Sr. Clinical Engineer works with several multi-functional teams to represent the needs of patients and clinicians throughout the design and development of new products. This individual will lead pre-clinical activities to drive product development towards a clinically impactful design. This role is influential to overall product strategy and the product's ability to positively impact patient and physician lives!

Your primary responsibilities will include, but are not limited to:

  • Serve as a liaison between clinicians and design teams

  • Collaborate with development teams to define and validate clinical requirements for products

  • Apply engineering methodologies and in-depth understanding of technical design, to solve clinical challenges

  • Conduct pre-clinical evaluation of new product prototypes

  • Analyze user feedback and provide clinical guidance to engineering teams to ensure product meets clinical safety and user needs

  • Apply knowledge of surgical procedures to establish models and experimental techniques to evaluate clinical performance

  • Work with product management to identify unmet clinical needs and define new solutions

  • Understand current state of end-user and patient environment

  • Assess clinical hazards and contribute to use-related risk analysis

  • Write protocols, conduct formal testing, and report results of validation and other studies

  • Collect feedback and insight about standard of care techniques and competitive products being used in the market

  • Attend key scientific conferences and engage clinicians to stay abreast of the latest methods and knowledge in surgery

    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.

Qualifications

Required:

  • Bachelor’s degree in Engineering or Applied Science

  • Minimum 1-year experience working in a medical technology company or other highly regulated industry

  • Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820

  • Must have strong analytical and problem-solving skills,

  • strong understanding of the product development process, and design controls

  • Ability to travel up to 20%, internationally and domestic

  • Ability to work at the Santa Clara, CA site

    Preferred:

  • Advanced Degree MS, MD, or PhD

  • Functional knowledge of human anatomy and physiology, basic knowledge of surgery

  • Must have a consistent track record of effectively and clearly communicating concepts, ideas and knowledge to other individuals and teams

  • Background or experience in any of robotics, 3D kinematics, controls, or vision systems

  • Experience with medical devices in a pre-clinical setting

  • Experience working with teams across multiple engineering fields, including mechanical, software, electrical, and visual/industrial design

  • Experience in the regulated medical device environment preferred, including document control processes, document approval processes, study archiving, data collection and phase/design reviews

Primary Location

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

Organization

Verb Surgical Inc. (6270)

Job Function

R&D

Requisition ID

2105941866W

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