Mechanical Design Engineer

Sira Consulting, an Inc 5000 company; Palo Alto (CA); In loco; USD 120.000 - 170.000; Tempo pieno

Descrizione del lavoro

Sira Consulting, an Inc 5000 company in the Palo Alto area, seeks a mechanical design engineer to drive medical device components from concept through production using Creo and SolidWorks.

The role emphasizes PDM/PLM lifecycle management (SAP-ECTR), ECO/ECR processes, and collaboration with QA, regulatory, manufacturing, and sourcing to bring a product to launch. Candidates should have strong GD&T, BOM, DHF experience, and a track record of manufacturability-focused design.

Competenze

• Experience designing mechanical components for medical devices with regulatory considerations.
• Strong GD&T knowledge and documentation.
• Experience with ECO/ECR processes and PLM systems.
• Familiarity with ISO 13485 and FDA requirements.

Mansioni

• Design mechanical components, assemblies, and systems for medical devices from concept to production.
• Manage lifecycle of components in PDM/PLM (SAP-ECTR) including ECO/ECR.
• Build and test prototypes to validate design against specs, ensuring safety and reliability.
• Select biocompatible, sterilizable materials balancing cost and performance.
• Optimize designs for manufacturability (DFM/DFA) and efficient production.
• Create detailed 2D drawings using Creo or SolidWorks.
• Apply GD&T to communicate tolerances precisely for manufacturing.
• Generate and maintain the BOM.
• Maintain Design History File (DHF) documenting the design process.
• Revise drawings and documentation; manage the engineering change order (ECO).
• Ensure design/documentation compliance with FDA and ISO 13485.
• Collaborate with QA, regulatory, manufacturing, and sourcing to launch products.

Strumenti

Creo

SolidWorks

SAP-ECTR

Descrizione del lavoro

• 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.