Kaleidoscope Innovation · 8 hours ago
Senior Clinical Engineer
Blue Ash, OH
Full-time
Onsite
Mid, Senior Level
3+ years expKaleidoscope Innovation is focused on advancing medical technology, and they are seeking a Senior Clinical Engineer to lead the development of procedures and devices for clinical studies. The role involves collaboration with clinical leads and development teams to design trial protocols and assess technologies to meet clinical needs.
IndustrialIndustrial DesignIndustrial EngineeringManufacturingMedical DevicePackaging ServicesProduct DesignSoftware Engineering
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
Qualification
Required
A bachelor's degree in a technical field and a strong understanding of biology are 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
An advanced degree (MS, PhD, MBA) is 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
Company
Kaleidoscope Innovation
When clients come to us for product design and development, they get a full range of technical expertise and laboratory resources, but they also get a team that’s relentless when it comes to solving problems and creating designs that are the ideal combination of function and form.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2020-09-03Acquired
Leadership Team
Elliott Fegelman
Chief Medical Officer
M
Michael Bunch
Senior Software Developer
Company data provided by crunchbase