R&D Intern (62992)

Role Summary: The 2027 R&D Intern will support the R&D and Quality teams by reviewing and organizing design control documentation, identifying gaps, and improving traceability across the Design History File (DHF) and Design Traceability Matrix (DTM). The intern will help ensure documentation is complete, consistent, and submission-ready, in alignment with internal QMS requirements.

Key Responsibilities:

• Review DHF indexes for completeness; identify missing, incomplete, or noncompliant records.
• Perform gap analyses and document discrepancies (missing deliverables, inconsistent versions/IDs, unclear evidence).
• Support design input collection and organization (user needs, risk management file, regulatory requirements, standards, labeling/IFU requirements).
• Confirm design inputs are clear/measurable, uniquely identified, and appropriately approved; separate user needs from design inputs.
• Review design outputs/specifications to ensure they are measurable/testable, follow the correct templates, and avoid vague/duplicate requirements.
• Map verification and validation evidence to design inputs/user needs; flag missing or unclear testing.
• Cross-check risk management documentation (e.g., FMEA/hazard analysis) to ensure risk controls are reflected in design inputs and specifications.
• Populate and refine DTM linkages (User Needs - Inputs - Outputs - Verification/Validation) and confirm forward/backward traceability.
• Perform document control and formatting checks (document numbers, revisions, approvals, SOP alignment) and help prepare submission-ready DHF packages.
• --Internship January 2027-May 2027

Required Qualifications:

• Currently pursuing a BS/MS in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Systems Engineering, or a related field.
• Strong attention to detail and ability to follow controlled documentation processes.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint); comfort working in structured templates.
• Ability to organize large sets of documents, track status, and maintain consistent identifiers/versioning.
• Clear written and verbal communication; ability to summarize gaps and questions for R&D/Quality stakeholders.
• --Internship January 2027-May 2027