Mechanical Engineer

Responsibilities    Translate  clinical and user requirements  – including clinician  feedback , diagnostic  imaging  (e.g., ultrasound), and  biomechanics – into  personalized device design methodologies 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.

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