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.