Kaleidoscope Innovation · 5 days ago
Staff Clinical Engineer
Blue Ash, OH
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expKaleidoscope Innovation is a company focused on medical technology and clinical studies. They are seeking a Staff Clinical Engineer to lead the development of procedures and devices for clinical trials, collaborating with healthcare providers and internal teams to ensure safety and efficacy in clinical investigations.
IndustrialIndustrial DesignIndustrial EngineeringManufacturingMedical DevicePackaging ServicesProduct DesignSoftware Engineering
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
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
Qualification
Required
A Bachelor's degree in a technical field, with a strong understanding of biology is 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
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
Ability to travel domestically and/or internationally 20%, with some periods up to 40% of the time required
Preferred
An advanced degree (MS, PhD, MBA) is preferred
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
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
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