Position Focus :
This primary focus of this position will be to support YNHH clinical cases with image segmentation, virtual surgical planning, patient-specific device design, and 3D printing of models and devices.
The initial case work will start in Orthopaedics but may expand to other specialties over time. This role will interface directly with physicians and attend surgeries in the hospital environment.
This role will require adherence to SOPs and thorough documentation of case work, with an understanding of ISO standards and FDA guidance on point of care 3D printing.
Secondarily, this role will support clinical research projects as requested, including device design and / or 3D printing of components.
Essential Duties
1. Carries out research within the scope of the established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies.
2. Develops criteria for admission of study subjects based on goals and objectives of project. 3. Determines potential sources of funding and prospective partnerships.
4. Evaluates feasibility of accepting potential projects through analysis of staffing needs, resource requirements, financial costs, and current planned capacity of group.
Negotiates contracts and / or changes with funder. 5. Develops original HIC / IRB submissions. Based on knowledge of science and research goals, collaborates with PIs on major revisions and contributes to scientific protocols.
Plans and implements changes. 6. Develops forms, questionnaires and the application of research techniques; writes procedures manuals for data collection and coding.
7. Responsible for the documentation and transmission of study data. Ensures that report forms are accurately documented and completed in a timely manner at each site location.
8. Works independently to develop manage and organize multi site studies. Serves as primary coordinator between University, non-Yale collaborators, pharmaceutical companies, HIC, IRB and funding sources.
9. Performs descriptive and multivariate statistical analyses of data, using computer software. 10. Designs and implements quality control measures to ensure accurate collection and processing of data.
11. Contributes in-depth, original thought and relevance to written reports and to the writing of abstracts and manuscripts.
Required Education and Experience
Master’s Degree in a related discipline and two years of experience or an equivalent combination of education and experience.
Required Skill / Ability 1 :
Ability to define and execute clinical workflows for image segmentation, virtual surgical planning, and 3DP patient-specific medical device design.
Required Skill / Ability 2 :
Ability to perform technical analysis and 3D research as requested. Ability to provide 3D support for other clinical interests and projects.
Required Skill / Ability 3 :
Source expertise for specific projects as needed. Maintain capital equipment 3D printers and associated equipment.
Required Skill / Ability 4 :
Track all clinical work per SOPs according to our quality management system.
Required Skill / Ability 5 :
Ability to work within a hospital environment adhering to all regulations (IRB, HIPAA, etc.).
Drug Screen
Health Screening
Background Check Requirements
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements.
All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.
COVID-19 Vaccine Requirement
The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here :
Posting Disclaimer
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position.
Employees will be assigned specific job-related duties through their hiring departments.