Preclinical Scientist; Robotics & Digital Solutions – MedTech Surgery

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://(Use the "Apply for this Job" box below)..comJob

Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Clinical Development & Research — Non-MD

Job Category:
Scientific/Technology

All Job Posting Locations:
Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America

About Surgery
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world.

Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness.

• Supports product evaluations involving animate, inanimate, and cadaveric models
• Performs research supporting development of products or procedures in minimally invasive robotic surgery
• Assisting or conducting investigations for medical device development and preclinical evidence generation aligned to R&D, Regulatory, and Commercial needs
• Coordinate and ensure accurate documentation of laboratory activities
• Conduct lab activities in compliance with USDA, AAALAC, and J&J Animal use policies
• Ensure compliance with 21 CFR Part 58 — Good Laboratory Practices
• Contribute and support the design of appropriate studies to meet premarket and post-market needs
• Design, plan and execute preclinical animal studies for the assessment of safety, performance, and effectiveness
• Act as study coordinator in support of the Study Director
• May act as Study Director on less complex projects
• Assess, communicate, and manage the risks associated to the preclinical evaluation of products.
• Assist in appropriate interpretation and dissemination of all evidence generated, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc.
• Demonstrate the ability to work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility.
• Build successful relationships internally and develop partnerships with key business partners.

• Minimum of a Bachelor’s Degree in Biological Science or a related discipline is required. An Advanced Degree (master’s or Ph.D.) is strongly preferred.
• At least 3+ years of related scientific / technical experience within clinical and/or preclinical research is required.
• Experience in clinical and/or preclinical science and processes along with an understanding of product development processes, related healthcare market environment, clinical trends, and/or preclinical or clinical trial regulations including In-Vivo is required.
• Proven track record of contributing to clinical and/or preclinical programs on time, within budget and in compliance to SOPs and regulations is required.
• Experience working in a GLP environment and direct experience executing preclinical GLP studies.
• Understanding of good documentation practices required.
• Familiarity with animal welfare regulations and IACUC is required.
• Large Animal experience is highly desired.
• Experience working in Medical Device and/or Robotics is preferred.
• Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is preferred.
• May require up to 15% domestic…