Clinical Engineer

The Clinical Engineers on this team bridge healthcare and medical technology by developing safe and effective intratumoral procedures and devices. They partner with physicians and cross-functional teams to design clinical studies, optimize procedures, and address unmet needs, while leading the development of study protocols and technologies that improve outcomes and support innovation across development programs. Also open to candidates in Cincinnati (OH) or Raritan (NJ) Key Responsibilities Serve as a liaison between external healthcare providers and internal Development Teams, representing the HCP/user and providing domain expertise. Lead the development of intratumoral therapy procedures and supporting documents/manuals for clinical trials, focusing on managing risk through appropriate medical technology and techniques. Identify critical tasks that ensure safety and efficacy and facilitate their successful implementation in clinical trial investigations. Development of procedure/devices sections of clinical documentation such as study protocols, regulatory submissions, and site requirements. Collaborate with SMEs to establish tumor and anatomical models and experimental techniques to evaluate clinical performance, risks, and technologies. Cleaning, reviewing and providing interpretation of procedure data within clinical trials. Work with clinical trial field team to identify clinical trial-specific insights, translate unmet needs, and mitigate risks within trial procedures. Gather feedback and insights on standard-of-care techniques and competitive products used in the market. Attend scientific conferences and engage healthcare providers to deepen understanding of cancer patient care, emerging research, regulations, and new technologies. Desired Skills and Experience Required Experience and Skills Three or more years of professional experience in the healthcare, pharmaceutical and/or medical device industries, with at least two years focused on product development within those industries. Experience with at least three of the following is required, with a demonstrated understanding of the remaining highly preferred: Human factors processes and usability studies. Use related risk identification and mitigation (e.g., uFMEA/aFMEA/URRA development). Facilitating physician interaction, voice of customer, and/or contextual inquiry/ethnography studies. Experiment development (designing, protocol, and report writing). Customer/User requirements development. Instruction for use development. A proven track record of teamwork, collaboration, inclusion, and developing strong business relationships with internal teams and outside partners. Prioritizing tasks, leading several projects at a time, and working efficiently by eliminating/overcoming low-priority tasks or non-value-added activities. Strong problem‑solving skills for developing creative solutions and meeting project objectives. The ability to present and communicate complex information, customer insights, and scenario and risk analyses to external partners, senior leaders, and technical teams. Preferred Experience as an industry representative in an operating room environment. Experience working within the head and neck (Ear, nose, and throat), anatomical space. Experience working within the lung/thoracic anatomical space. Medical device development experience, preferably late‑stage development / working with design controls. Drug device combination product development experience. Experience working within clinical trials. Experience negotiating with and influencing collaborators.Experience with domestic and international collaboration. Other Ability to travel domestically and/or internationally 20%, with some periods up to 40% of the time required. Education A bachelor's degree in a technical field and a strong understanding of biology are required. An advanced degree (MS, PhD, MBA) is preferred. Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #J-18808-Ljbffr Real