Mechanical Design Engineer

Excelon Solutions; Palo Alto (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Excelon Solutions seeks a Senior Mechanical Design Engineer with 8+ years of medical device design experience. You will lead subsystems from concept to release using Creo/SolidWorks, GD&T, and DFM/DFA to ensure manufacturability.

You will collaborate across disciplines (Systems, Electrical, Software, Quality, Regulatory) and drive prototype builds, testing, and verifications while maintaining rigorous design controls and documentation per FDA/ISO 13485 standards.

Qualifications

• 8+ years of mechanical design experience in medical devices.
• Strong CAD proficiency in Creo and SolidWorks with attention to detail.
• Experience with PDM/PLM systems and ECO/ECR processes (SAP-ECTR).
• Expertise in GD&T and tolerance analysis for manufacturability.
• Familiarity with Design Controls, risk assessment (FMEA), and V&V activities.

Responsibilities

• Lead mechanical subsystem development from concept through detailed design, prototyping, testing, and release.
• Create 3D CAD models and engineering drawings with GD&T and tolerance stack-ups.
• Translate requirements into manufacturable mechanical designs and select appropriate materials.
• Support system integration and address mechanical/electrical/interface issues.
• Develop test methods and support design verification activities.
• Drive prototype builds, design iterations, testing, troubleshooting and root-cause analysis.
• Collaborate with Systems, Electrical, Software, Quality, Regulatory, Manufacturing, and suppliers.
• Participate in design reviews, risk analysis, Design Controls, and design transfer activities.
• Ensure documentation adheres to FDA and ISO 13485 requirements.

Skills

Creo

SolidWorks

PDM/PLM

GD&T

Tolerance stack-up

DFM/DFA

BOM management

DHF documentation

ECO process

Regulatory awareness

Design reviews

FMEA risk analysis

V&V

Tools

Creo

SolidWorks

SAP-ECTR

Job description

• 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.

Title: Senior Mechanical Design Engineer(8+ Years)

Need someone with 8+ Years experience.

JD:

• Lead mechanical subsystem development from concept and requirements through detailed design, prototyping, testing, and release
• Strong hands-on experience with 3D CAD, engineering drawings, GD&T, tolerance stack-up, material selection, and DFM/DFA.
• Experience designing mechanisms, precision assemblies, structures, enclosures, motion systems, or electromechanical products.
• Apply engineering analysis for structural, thermal, vibration, fatigue, and reliability considerations as applicable.
• Translate product/system requirements into practical and manufacturable mechanical designs.
• Support system integration and resolve mechanical, electrical, manufacturing, and interface-related issues.
• Develop engineering test methods and support design verification activities.
• Select appropriate materials by considering factors critical in the medical industry, such as biocompatibility, sterilization compatibility, and cost-effectiveness.
• Drive prototype builds, design iterations, testing, troubleshooting, and root-cause analysis.
• Participate in design reviews, risk analysis/FMEA, Design Controls, V&V, and design transfer activities.
• Collaborate with Systems, Electrical, Software, Quality, Regulatory, Manufacturing, and suppliers.
• Experience supporting early-stage product development, rapid prototyping, and technology maturation is preferred