Job description
As a Field Clinical Engineer, you will play a pivotal role in supporting the on-site execution of our first pivotal clinical study for our active implantable medical device, collaborating closely with hospital staff, including physiotherapists, and various study partners. Acting as the crucial link between healthcare facilities and our company, you will enhance our understanding of SCI and neurological rehabilitation practices. Your primary responsibilities include building and maintaining strong relationships with investigational sites, providing comprehensive technical support, and ensuring the highest level of compliance and adherence to Good Clinical Practice (GCP) standards.
Responsibilities- Implement and coordinate clinical study activities in hospitals within your respective region, ensuring a seamless and efficient execution of study protocols.
- Provide technical, clinical, and neuromodulation programming assistance, staff education, and technical troubleshooting.
- Assist in the training of sites and study staff on technical aspects of the study protocol and procedures.
- Assist sites with pre-screening activities to ensure appropriate candidates for study inclusion.
- Proficient in complex programming, case support.
- Assist in after-hours call support and activities.
- Provide feedback to providers both within operating room setting and outside operating room setting on the directions for use specific to implantable devices.
- Foster high-trust relationships with customers, including the regional team members.
- Collaborate with clinical centers and the ONWARD medical clinical and regulatory team to guarantee the smooth enrollment of subjects and maintain the highest quality data collection in accordance with GCP requirements.
- Work closely with study vendors, and CRAs to coordinate site-level activities and facilitate timely compliance with study protocol procedures, as well as the accurate reporting of data.
- Collaborate with the Product Development team to facilitate the transfer of comprehensive technical knowledge to the clinical team and study centers. Conversely, contribute by bringing valuable insights from rehabilitation practices, clinical expertise, and user feedback back to the company.
- Manage efficient device-related Quality reporting.
- Document any key compliance actions.
- Provide hands-on technical and clinical training and support on-site during study-related surgical operations or rehabilitation procedures, ensuring the safe and effective use of medical devices.
- Maintain current knowledge and comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Good Clinical Practices (GCP), Company policies, operating procedures, processes, and task assignments.
Experience, Qualifications & 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.
Prior patient interaction experience in a healthcare-related environment preferred.
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.
SupervisionIndividual Contributor reporting to our Senior Director Clinical Operations.