Mechanical Design Engineer

Job Title: Mechanical Design Engineer II – Medical Device

Job Location: Lafayette, Colorado (Fully onsite)

Type: W2 contract

Duration: 12 months

We are seeking a Mechanical Design Engineer II with hands-on experience in medical device development, 3D CAD tools (CREO/SolidWorks), and mechanical/electromechanical product design. The ideal candidate must have strong knowledge of FDA QSR, ISO 13485, IEC 60601, ISO 14971, and medical device regulatory standards.

Core Skills:

• 3D Modeling (CREO, SolidWorks)
• Mechanical & Electromechanical Assembly Design
• GD&T, DFSS, DFMA, Tolerance Analysis, DFMEA
• Compliance with FDA & international medical device standards
• Experience with drafting standards and design validation

Education & Experience:

• Bachelor’s in Mechanical Engineering
• Minimum 2 years of relevant experience

Role Summary:

Design and develop innovative medical device components and systems, ensure regulatory compliance, optimize product performance, and support transfer from R&D to manufacturing.