Staff Clinical Engineer

As a Clinical Engineer, you will lead the development of procedures and devices that support clinical studies critical to the success of INTO’s cross-sector Development Teams. You will guide the team in medical technology and procedures, working closely with clinical leads and principal investigators to design clinical trial protocols and procedural documentation. Additionally, you will identify optimal intratumoral procedure flow, unmet needs, and risks and assess technologies for their ability to mitigate those risks or meet those needs.

• 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.
• Lead the development and tracking of procedure endpoints within clinical trials, including development of data collection, analysis plans, and interpretation of procedural data.
• Identify, document, and translate clinical trial insights, unmet needs, and market feedback into opportunity statements, user requirements, and design solutions.
• Provide suggestions and recommendations to leadership on new opportunities, strategies, and tactics.
• Deliver oral and written presentations to management to support approval, funding, and execution of new initiatives.
• Attend scientific conferences and engage healthcare providers to deepen understanding of cancer patient care, emerging research, regulations, and new technologies.

Education:

• A Bachelor’s degree in a technical field, with a strong understanding of biology is required.
• An advanced degree (MS, PhD, MBA) is preferred.

Required:

• Five or more years of professional experience in the healthcare, pharmaceutical and/or medical device industries. With at least 3 years focused on product development within healthcare, pharmaceutical and/or medical device industries.
• Experience with at least 4 of the following is required, with a demonstrated understanding of the remaining highly preferred:
• Human factors processes and usability studies.

1. Use related risk identification and mitigation (e.g., uFMEA/aFMEA/URRA development).
2. Facilitating physician interaction, voice of customer, and/or contextual inquiry/ethnography studies.
3. Experiment development (designing, protocol, and report writing).
4. Customer/User requirements development.
5. Instruction for use development.

• Proven record of teamwork, collaboration, inclusion, and developing strong business relationships with internal teams and outside partners is required.
• Prioritizing tasks, leading several projects at a time, and working efficiently by eliminating/overcoming low-priority tasks or non-value-added activities are required.
• Strong problem-solving skills for developing creative solutions and meeting project objectives are required.
• The ability to present and communicate complex information, user insights, and scenario and risk analyses to external partners, senior leaders, and technical teams is required.

• 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.

• Ability to travel domestically and/or internationally 20%, with some periods up to 40% of the time required

Kaleidoscope, an Infosys Company, is an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, spouse of protected veteran, or disability.