S
Sira Consulting, an Inc 5000 company
Mechanical Design Engineer
Skills
Testing & QASAP ERP
12 days ago
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Important information
Contract type:
Freelance / Contract
Location:
Palo Alto, CA, USA
Work mode:
Onsite
Published on:
15 October 2026
What they need
- Design mechanical components, assemblies, and systems for medical devices from concept to production using Creo & SolidWorks.
- Hands-on experience in PDM / PLM (SAP-ECTR) for managing lifecycle of the components, managing ECO / ECR (SAP).
- Build and test prototypes to validate design performance against specifications and ensure safety and reliability.
- Select appropriate materials by considering factors critical in the medical industry, such as biocompatibility, sterilization compatibility, and cost-effectiveness.
- (DFM/DFA): Designs are optimized to ensure they can be efficiently produced and assembled, considering manufacturing processes.
- Using advanced CAD software such as Creo or SolidWorks, create detailed 2D drawings of components and assemblies.
- Apply Geometric Dimensioning and Tolerancing (GD&T) to communicate design tolerances and specifications precisely for accurate manufacturing.
- Generate and maintain the BOM, which is a comprehensive list of all raw materials, components, and assemblies needed to manufacture the final product.
- Organize and maintain a comprehensive Design History File (DHF), which documents the entire design process, including inputs, outputs, verification, and validation records.
- Revising and updating technical drawings and documentation as needed and for managing the engineering change order (ECO) process.
- Ensuring all design and documentation adheres to strict medical device regulations from bodies like the FDA and standards like ISO 13485.
- Work with a range of professionals, including quality assurance, regulatory affairs, manufacturing and sourcing, to bring a product from concept to launch.
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