Translate clinical and user requirements – including clinician feedback, diagnostic imaging (e.g., ultrasound), and biomechanics– into personalized device designmethodologies and functional prototypes.

Develop and refine 3D CAD models, design heuristics, and tools to guide shape selection, parameterization, and manufacturable design, incorporating industrial design principles.

Lead device testing, evaluations, and iterative improvements based on anatomical function, clinical studies, and regulatory feedback.

Conduct physical testing(compression, bending, cyclic loads), FEA and/or mathematical modeling, to optimize device performance.

Maintain Design History Files (DHF), perform risk analyses (FMEA), and ensure compliance with ISO 13485, IEC 60601/62366 (safety and usability engineering), and FDA requirements.

Investigate root cause issues and drive corrective actions related to product quality and manufacturability.

Work closely with leadership on intellectual property (patents) and novel product innovations.

Collaborate on automated software workflows, integrating digital health and custom manufacturing solutions.

Support process development, including tooling, 3D printing, silicone injection, and other manufacturing techniques.

Assist in supplier assessments, part quality verification, and process validations.