Mechanical Design Engineer

Denver, CO, US • Posted 3 days ago • Updated 2 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

  • 3D Computer Graphics
  • Auditing
  • Regulatory Compliance
  • Collaboration
  • Management
  • Mechanical Engineering
  • Medical Devices
  • SolidWorks
  • ISO 9000
  • Design Controls
  • Product Development
  • Testing

Summary

Roles & Responsibilities:
  • Lead new product development from proof-of-concept through design verification for a needle-free drug delivery application, following a stage-gate NPD process
  • Create, refine, and release 3D models and production drawings for disposable and syringe-based components using SolidWorks
  • uthor and maintain Design History Files (DHF) and support audits, inspections, and regulatory compliance activities
  • Ensure adherence to ISO and FDA design control requirements throughout the development process
  • Optimize designs for manufacturability and scale-up in collaboration with contract manufacturers and key suppliers
  • Manage prototype builds, testing iterations, and design refinements through vendor engagement and validation activities
Education & Experience:
  • bachelor's degree in mechanical engineering
  • Minimum of 2+ years of mechanical design experience, preferably in medical devices within a regulated environment
  • Proficiency in SolidWorks
  • Working knowledge of ISO and FDA design controls
  • Experience supporting new product development from concept through testing and validation
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: f42c7fdc98b513f710d5b8889c39fb3c
  • Posted 3 days ago
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