Johnson & Johnson MedTech · 8 hours ago
Sr. Field Clinical Engineer - Shockwave Medical
Johnson & Johnson MedTech is a leader in healthcare innovation, seeking a Sr. Field Clinical Engineer to support clinical trials for Shockwave Medical products. This role involves developing recruitment strategies, providing case support, and ensuring effective training and data collection for clinical programs.
Hospital & Health Care
Responsibilities
Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices
Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms
Provide clinical and technical support for key study investigators and clinical leaders at assigned sites
Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues
Administrative activities including training to procedures at site level
Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals
Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools
Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked
Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals
Partner with assigned physician advisors to create and deliver recruitment strategies
Partner with vendors that support recruitment activities
Other duties as assigned
Qualification
Required
Bachelor's Degree in a scientific field of study or equivalent work experience
Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional Cardiology or surgical procedures in a cardiovascular Lab
Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials
Thorough knowledge of Good Clinical Practice (GCP) is required
Ability to attain and maintain hospital credentials
Ability to work in a fast-paced environment while managing multiple priorities
Operate as a team and/or independently while demonstrating flexibility to changing requirements
Experience with electronic data capture (EDC) systems
Must have excellent verbal and written communication skills
High attention to detail and accuracy
Able to manage multiple project teams with guidance
Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.)
Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America
May be required to lift up to 25 pounds
Preferred
Analytical Reasoning
Business Behavior
Clinical Operations
Clinical Research and Regulations
Clinical Trial Designs
Coaching
Communication
Ethical and Participant Safety Considerations
Innovation
Laboratory Operations
Office Administration
Preclinical Research
Problem Solving
Project Management
Project Schedule
Research and Development
Study Management
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.