Medical Device Mechanical Design Engineer (Creo/SolidWorks)

Sira Consulting, an Inc 5000 company; Palo Alto (CA); Sur place; USD 120 000 - 170 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Outils

Creo

SolidWorks

SAP-ECTR

Description du poste

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.