Field Clinical Engineer

ONWARD Medical•,

16d•Onsite

About The Position

As a Field Clinical Engineer, you will support the on-site execution of the company’s first pivotal clinical study for an active implantable medical device. You will work closely with hospital staff, including physiotherapists, and study partners, serving as a link between healthcare facilities and the company and helping deepen understanding of spinal cord injury and neurological rehabilitation practices. The role provides technical, clinical, and neuromodulation programming support to investigational sites, assists with patient recruitment and enrollment, and supports study execution in accordance with protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. It is field-based, involves regular travel to investigational sites, and may require after-hours support for study activities. The role reports to the Senior Director Clinical Operations.

Requirements

Bachelor’s degree or technical certification; an engineering background is preferred.
At least 3 years of clinical field experience involving direct physician interaction in operating room environments, including engagement with Key Opinion Leaders.
At least 3 years of experience with spinal cord stimulation (SCS) or other implantable medical devices.
Demonstrated experience supporting clinical research studies, pre-market and/or post-market, in compliance with GCP standards.
Commitment to patient safety, protocol adherence, and Class III regulatory requirements.
Strong organizational, communication, and prioritization skills, including the ability to manage multiple tasks under tight deadlines.
Strong problem-solving mindset and sense of urgency.
Ability to communicate complex topics to diverse clinical and technical audiences.
Adaptable, team-oriented approach and comfort working in fast-paced, matrixed environments with unpredictable schedules.
Willingness to travel up to 75%, including occasional international travel.

Nice To Haves

Engineering background.
Experience in neurological rehabilitation.
Prior patient interaction experience in a healthcare-related environment.

Responsibilities

Support and coordinate clinical study activities at investigational sites in the assigned region to ensure efficient execution of study protocols.
Build and maintain relationships with investigational sites, investigators, study coordinators, physiotherapists, and other stakeholders.
Support patient identification, recruitment, pre-screening, and enrollment in accordance with the study protocol and approved recruitment practices.
Work with sites to identify patient recruitment and enrollment barriers and support appropriate solutions.
Provide technical, clinical, and neuromodulation programming assistance, including complex programming, case support, staff education, and troubleshooting.
Assist in training sites and study staff on study protocol technical aspects, device use, and study procedures.
Provide on-site technical and clinical support during study-related surgical operations and rehabilitation procedures to promote safe and effective device use.
Guide healthcare professionals inside and outside the operating room on the Directions for Use for the implantable device.
Collaborate with clinical centers and the Clinical and Regulatory teams to support timely participant enrollment and high-quality data collection in accordance with GCP.
Coordinate site-level activities with study vendors and CRAs, facilitate protocol compliance, and support accurate and timely data reporting.
Communicate site needs, enrollment challenges, technical issues, and clinical feedback to the company.
Collaborate with Product Development to transfer technical knowledge to the clinical team and study centers, and share rehabilitation practices, clinical experience, and user feedback with the company.
Support timely device-related quality reporting and document compliance-related activities.
Provide after-hours support when required for study-related activities.
Maintain knowledge of and comply with FDA regulations, other regulatory requirements, GCP, study protocols, and company policies and procedures.