JOB POSTING DESCRIPTION

The Musculoskeletal Digital Innovation and Informatics (MDI2) Program in the Department of
Orthopedic Surgery at Boston Children’s Hospital and Harvard Medical School has an immediate
opening for an outstanding, highly motivated Research Assistant to assist with several translational
projects focused on development of medical software and data processing pipelines to assist with
clinical care, research and operation. The Research Assistant will directly work with a
multidisciplinary team of biomedical engineers, software engineers and data scientists for each
project. Primary tasks include but not limited to performing documentation of medical software
for operation, version control and regulatory compliance, ensuring clear and accurate technical
descriptions. Work closely with software engineers to document code functionality, risk analysis,
and validation details. Assist with data review and annotation for AI model training, testing and
validation.

The Research Assistant will be responsible for:

• Reading and interpreting Python and MATLAB codes to document software functionality, design, and intended use
• Preparing technical documentation, including Manual of Operation, Software Description, Risk Analysis, and Verification/Validation reports, following provided templates and guidance
• Working with engineers to clarify software behavior and ensure documentation accuracy
• Organizing and formatting regulatory submission documents to meet FDA guidelines, under the direction of the regulatory consultant
• Assisting in maintaining and updating technical documentation as software evolves
• Reviewing and annotating clinical data (imaging and notes) for training, testing and validation of AI models.
• Conducting literature searches and reviews, compiling information for journals and suggesting uses for new techniques to the P.I.
• Attending courses, lectures and conferences to further own knowledge of research and laboratory techniques, consulting with other researchers and technicians to exchange information
• Contributing to the team within and between departments and organizations

To qualify, you must have

• A Bachelor’s degree in STEM or related area is required
• Basic understanding of coding and familiarity with Python and MATLAB coding platforms
• Analytical skills to resolve problems that require the use of basic scientific, mathematical, or technical principles
• Strong technical writing and documentation skills - able to explain software functions clearly
• Experience organizing technical documents (e.g., manuals, reports) in a structured and professional format
• No prior regulatory experience required - guidance provided by a regulatory consultant
• Familiarity with medical software development is preferred but not required

• Reading and interpreting Python and MATLAB codes to document software functionality, design, and intended use
• Preparing technical documentation, including Manual of Operation, Software Description, Risk Analysis, and Verification/Validation reports, following provided templates and guidance
• Working with engineers to clarify software behavior and ensure documentation accuracy
• Organizing and formatting regulatory submission documents to meet FDA guidelines, under the direction of the regulatory consultant
• Assisting in maintaining and updating technical documentation as software evolves
• Reviewing and annotating clinical data (imaging and notes) for training, testing and validation of AI models.
• Conducting literature searches and reviews, compiling information for journals and suggesting uses for new techniques to the P.I.
• Attending courses, lectures and conferences to further own knowledge of research and laboratory techniques, consulting with other researchers and technicians to exchange information
• Contributing to the team within and between departments and organization