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Mechanical Design Engineer

Conflux Systems, Inc.

Austin, TX

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JOB DETAILS
SKILLS
CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Cross-Functional, Data Analysis, Design Services, Documentation, Logistics, Maintain Compliance, Manufacturing, Mechanical Design, Mechanical Engineering, Medical Equipment, Medical Products, Problem Solving Skills, Procedure Development, Product Development, Product Lifecycle, Prototyping, Purchasing/Procurement, Regulatory Requirements, Reporting Skills, Root Cause Analysis, SolidWorks, Statistics, Technical Leadership, Technical/Engineering Design, Testing, Validation Testing
LOCATION
Austin, TX
POSTED
30+ days ago
No Sponsorship/Contract W2   We are seeking a skilled Senior Mechanical Design Engineer with strong expertise in medical device product development. The ideal candidate will play a key role in design changes, maintenance releases, and ensuring regulatory compliance throughout the product lifecycle.

Must-Have Skills:
  • Proven experience in implementing design changes and maintenance releases for medical device products.
  • Hands-on mechanical design experience including prototyping and testing.
  • Proficiency in SolidWorks or similar CAD tools for creating detailed drawings and assemblies.
  • Experience maintaining and updating design history files (DHFs).
  • Strong background in root cause analysis and issue resolution in medical devices.
Nice-to-Have Experience:
  • Collaborating with external vendors.
  • Conducting data/statistical analysis and preparing technical reports.
  • Developing test procedures for verification and validation.
  • Managing field complaints.
  • Assessing production impacts of design changes and working cross-functionally with purchasing and production teams.
Key Responsibilities:
  • Design, configure, and engineer mechanical solutions to meet customer and regulatory requirements.
  • Define product components, ensure functional integration, and create detailed design documentation.
  • Support manufacturing, procurement, and logistics to ensure successful implementation.
  • Provide technical guidance and functional expertise across teams and projects.
Qualifications & Experience:
  • 8–10 years of experience in mechanical design, preferably in the medical device industry.
  • Strong problem-solving skills and ability to apply deep domain expertise across various contexts.
  • Bachelor’s or Master’s degree in Mechanical Engineering or related field.

About the Company

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Conflux Systems, Inc.