Preclinical Research Technologist

About the role

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 MedTech surgery? Ready to join a team that’s reimagining how we heal? Our MedTech 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. Learn more at https://jnjmedtech.com We are searching for the best talent for a Preclinical Research Technologist who will support preclinical research activities for medical device development, including product evaluations in animate, inanimate, and cadaveric models. Working under significant guidance and supervision, this role contributes to study execution, laboratory documentation, study logistics, and compliance with Good Laboratory Practices, animal welfare regulations, and internal policies. The position partners with cross-functional teams to help generate high-quality preclinical evidence that supports research, regulatory, and commercial objectives. This will be an on-site position.

Responsibilities

• Supports and assists in product evaluations involving animate, inanimate, and cadaveric models
• Supports research and development of products or procedures in minimally invasive robotic surgery
• Assisting in the investigations for medical device development and preclinical evidence generation aligned to R&D, Regulatory, and Commercial needs
• Ensure accurate documentation of laboratory data and activities under the direction of the Study Director or Study Coordinator
• Assists in study logistics; e.g. pick-lists, instrument and supply requests, device transfers, study binder creation
• Helps to ensure that the conduct of lab activities are in compliance with USDA, AAALAC, and J&J Animal use policies
• Helps ensure compliance with 21 CFR Part 58 – Good Laboratory Practices
• Supports the generation/revision of SOPs, study documentation, and data collection documents for non-GLP and GLP study protocols
• Supports preclinical animal studies for the assessment of safety, performance, and effectiveness
• 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

Requirements

• Bachelors degree preferred but not required
• Familiarity with FDA 21 CFR part 58 (GLPs)
• A minimum of 2 years of related technical experience within preclinical research or research/laboratory environment is required.
• Familiarity with preclinical processes along with a basic understanding of medical device development processes and preclinical regulations is required.
• Experience working in a GLP environment is preferred
• Understanding of good documentation practices
• Familiarity with animal welfare regulations and IACUC

Skills

• Accountability
• Analytical Reasoning
• Data Management and Informatics
• Data Savvy
• Detail-Oriented