Senior Clinical Engineer

Senior 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 procedure flow, unmet needs, and risks and assess technologies for their ability to mitigate those risks or meet those needs.

Key Responsibilities:

•Serve as a liaison between external healthcare providers and internal Development Teams, representing the voice of the customer and providing domain expertise.

•Lead the development of procedures for intratumoral therapy and clinical trials, focusing on managing risk through appropriate medical technology and techniques.

•Assist with developing clinical trial documentation such as study protocols, regulatory submissions, and participating site requirements.

•Collaborate with pre-clinical teams to establish models and experimental techniques to evaluate clinical performance, evaluate clinical risks, and assess technologies.

•Collaborate with Field Clinical Managers to identify clinical trial-specific insights that can be translated into unmet needs and mitigate risks within the trial

procedures.

Document, quantify, and translate insights into opportunity statements and customer requirements to guide product development.

•Collate feedback and insights on standard-of-care techniques and competitive products used in the market. Collaborate with strategic marketing and development engineering partners to evaluate unmet clinical needs and define new solution embodiments.

•Attend key scientific conferences and engage healthcare providers to build a deep clinical understanding of cancer patient care, emerging areas of research, regional and site-specific regulations and policies, and the potential benefits of new technologies.

Qualifications

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.

Experience and Skills:

Required:

•Three or more years of professional experience in the healthcare, pharmaceutical and/or medical device industries.

•With at least 2 years focused on product development within pharmaceutical and/or medical device industries.

•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.

•Experience with at least 3 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 requirements development.
• Instruction for use development.

•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.

•Medical device development experience, preferably late-stage development.

•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.

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.