描述
Johnson and Johnson MedTech Robotics and Digital Surgery is recruiting for a Principal Scientist within the Preclinical Engineering team. The position is located in Santa Clara, California!
Johnson & Johnson MedTech 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.
Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon 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 robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our dedication to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com
The Preclinical Principal Scientist for J&J MedTech Robotics and Digital Solutions will serve as a scientific contributor and project leader for the development and execution of strategies for preclinical evidence vital to competitively position Ethicon/RAD products for domestic and international regulatory and clinical acceptance. Working closely with Preclinical platform/franchise leaders, the Principal Scientist will independently design, execute, and analyze and interpret preclinical studies to understand the safety and efficacy of product concepts. The individual will work closely across functional groups within JNJ and external to the company to meet project objectives and timelines.
Key Responsibilities:
- Represent Preclinical Engineering on R&D project teams.
- Provide preclinical scientific input on the evaluation of safety and efficacy for technologies and products at all stages of the product life cycle.
- Responsible for partnering and contributing to the Target Product Profile (TPP), evidence generation strategies, and the project per New Product Development stage gate process with the Preclinical platform leader and other functional members.
- Creates the Preclinical Strategy and test plan and oversees study execution per project timelines.
- Responsible for planning and leading all aspects of preclinical studies in various models (e.g. in vivo, ex vivo, synthetic) for front end research, concept and prototype development, Safety, and Design Verification/Validation studies for regulatory submissions.
- Serve as a point of contact for communication between the project team and functional groups within Preclinical Engineering.
- Communicates progress and achievement status to preclinical leadership, R&D partners, and others.
- Collaborate cross-functionally with Operations, Quality Assurance, Marketing, Research and Development (R&D), Regulatory, Biocomp/Toxicology, Claims and other functional groups as needed.
- Collaborate with industrial design and human factors group to create robust usability evaluations. Participate in evaluations, as needed, to develop understanding of customer unmet needs, potential misuse situations and help interpret customer feedback to R&D team.
- Surveys the literature to identify and compare competitive product performance and safety risks.
资格
Education:
- Doctorate or master’s degree preferred. Bachelor’s degree required. Degree in biological sciences, biomedical engineering or a veterinary medicine or related field.
- With Doctorate or master’s degree, demonstrated ability (8+ years) in a medical device or pharmaceutical setting is required. With a bachelor’s degree, proven experience, and ability (10+ years) required in a medical device or pharmaceutical setting.
Experience and Skills:
Required:
- Proven ability to work across functions and influence a program direction is required.
- Extensive knowledge of preclinical research and experience with leading GLP and non-GLP preclinical studies.
- Track record of new product introduction and product life cycle management is required.
- Knowledge of preclinical regulatory requirements for FDA and other notified bodies is required.
- Excellent communication skills – written/oral/listening is required.
- Ability to clearly document and communicate plans and results is required.
- Lead and work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility is preferred.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
- The anticipated base pay range for this position is $111,000 to $192,050
- The base pay range for this position in the Bay Area of California is $128,000 to $220,915
- Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below:
https://www.careers.jnj.com/employee-benefits
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.
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.
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.