Sr. R&D Sustaining Engineer

Overview

On Site
Full Time

Skills

Research and Development
Testing
Regulatory Compliance
Collaboration
Manufacturing
Procurement
Design Documentation
Mentorship
Medical Devices
Mechanical Engineering
Prototyping
SolidWorks
Documentation
Root Cause Analysis
Conflict Resolution
Problem Solving
Statistics
Verification And Validation
Purchasing
Privacy
Marketing

Job Details

Location: Austin, TX
Salary: Negotiable
Description: Our client is currently seeking a Sr. R&D Sustaining Engineer

We are seeking a Senior R&D Sustaining Engineer to join our growing Platform Sustaining Engineering group. This is a critical new role created to support a recently launched medical device product. You will play a key part in maintaining and improving existing designs, ensuring product quality, and supporting cross-functional teams through the product lifecycle.
This job will have the following responsibilities:
  • Lead and execute design changes and maintenance releases for medical device products.
  • Perform hands-on mechanical design, including prototyping and testing.
  • Create and revise detailed drawings and assemblies using SolidWorks or similar CAD tools.
  • Maintain and update design history files in compliance with regulatory standards.
  • Conduct root cause analysis and implement corrective actions for product issues.
  • Collaborate with manufacturing, procurement, and quality teams to ensure seamless integration of design changes.
  • Prepare comprehensive design documentation and technical reports.
  • Provide functional guidance and mentorship to junior engineers.


Must-Have Skills:
  • Proven experience with design changes and sustaining engineering in medical devices.
  • Strong mechanical design and prototyping skills.
  • Proficiency in SolidWorks or equivalent CAD software.
  • Experience maintaining design history files and documentation.
  • Expertise in root cause analysis and problem-solving in regulated environments.

Nice-to-Have Experience:
  • Working with external vendors and suppliers.
  • Data and statistical analysis for product performance.
  • Developing and executing verification and validation test procedures.
  • Handling field complaints and implementing design improvements.
  • Assessing production impacts and collaborating with purchasing and production teams.


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Contact:

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