Mechanical Design Engineer / Medical device

Job Title: Mechanical Design Engineer / Medical device

Location: Palo Alto, CA

Key Responsibilities:

Design and draft sheet metal components using CAD tools such as SOLIDWORKS and Creo.

Develop and prototype mechanical components in accordance with design specifications.

Apply Geometric Dimensioning and Tolerancing (GD&T) principles and perform tolerance stack-up analysis.

Conduct functional and performance testing of mechanical prototypes and document the results.

Create and maintain Bills of Materials (BOMs) and manage Engineering Change Requests (ECRs) using SAP.

Ensure designs comply with safety regulations, quality standards, and product design requirements.

Support continuous improvement initiatives in both product design and manufacturing processes.

Adhere to regulatory requirements for Medical devices, including ISO 13485 and FDA standards.

Prepare and maintain detailed technical documentation for Design History Files (DHF).

Collaborate closely with cross-functional teams including R&D, manufacturing, and quality assurance to ensure design feasibility and production readiness.