Note: The job is a remote job and is open to candidates in USA. ONWARD Medical is developing an active implantable medical device for spinal cord injury and neurological rehabilitation. The Field Clinical Engineer Consultant will support the execution of a pivotal clinical study by coordinating investigational site activities, providing technical and clinical device support, assisting with patient recruitment and enrollment, and ensuring compliance with GCP and regulatory requirements.
Responsibilities
- Support and coordinate clinical study activities at investigational sites within the assigned region, ensuring seamless and efficient execution of study protocols
- Build and maintain strong relationships with investigational sites, investigators, study coordinators, physiotherapists, and other relevant stakeholders
- Support sites with patient identification, recruitment, pre-screening, and enrollment activities to help achieve study enrollment objectives in accordance with the study protocol and approved recruitment practices
- Work closely with investigational sites to identify potential barriers to patient recruitment and enrollment and support the implementation of appropriate solutions
- Provide technical, clinical, and neuromodulation programming assistance, including complex programming, case support, staff education, and technical troubleshooting
- Assist in the training of sites and study staff on the technical aspects of the study protocol, device use, and study procedures
- Provide hands-on technical and clinical support on-site during study-related surgical operations and rehabilitation procedures, ensuring the safe and effective use of the medical device
- Provide guidance to healthcare professionals, both within and outside the operating room setting, on the Directions for Use specific to the implantable device
- Collaborate with clinical centers and the ONWARD Medical, Clinical, and Regulatory teams to support the timely enrollment of study participants and maintain the highest quality of data collection in accordance with GCP requirements
- Work closely with study vendors and CRAs to coordinate site-level activities, facilitate timely compliance with study protocol procedures, and support accurate and timely data reporting
- Serve as a key link between investigational sites and ONWARD, communicating site needs, enrollment challenges, technical issues, and relevant clinical feedback
- Collaborate with the Product Development team to facilitate the transfer of technical knowledge to the clinical team and study centers. In return, bring valuable insights from rehabilitation practices, clinical experience, and user feedback back to the company
- Support efficient and timely device-related Quality reporting and document key compliance-related activities
- Provide after-hours support when required for study-related activities
- Maintain current knowledge of and comply with applicable U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Good Clinical Practice (GCP), study protocols, and applicable ONWARD policies and procedures
Skills
- Bachelor's degree or technical certification; engineering background preferred
- Minimum 3 years of clinical field experience with direct physician interaction in operating room environments, including engagement with Key Opinion Leaders
- Minimum 3 years of experience with spinal cord stimulation (SCS) or other implantable medical devices; experience in neurological rehabilitation is a plus
- Demonstrated experience supporting clinical research studies (pre- and/or post-market) in compliance with Good Clinical Practice (GCP) standards
- Strong commitment to patient safety, protocol adherence, and Class III regulatory requirements
- Excellent organizational, communication, and prioritization skills; able to manage multiple tasks under tight deadlines
- Strong problem-solving mindset with a sense of urgency
- Effective communicator able to translate complex topics for diverse clinical and technical audiences
- Adaptable, team-oriented, and comfortable working in fast-paced, matrixed environments with unpredictable schedules
- Willingness to travel up to 75%, including occasional international travel
- Prior patient interaction experience in a healthcare-related environment preferred
Benefits
- Field-based work arrangement with regular travel to investigational sites
Company Overview
Company H1B Sponsorship