Design Engineer

We are seeking a Senior Design Engineer with 5+ years of experience in medical device product design and development. The ideal candidate will lead the design and development of Class II/III medical devices from concept through commercialization while ensuring compliance with industry regulations and quality standards., * Design and develop medical device components and assemblies.

• Create and review 3D CAD models and engineering drawings using SolidWorks or Creo.
• Perform GD&T, DFMEA, Design Verification & Validation (V&V), and Design for Manufacturability (DFM).
• Support prototype development, testing, product improvements, and commercialization.
• Collaborate with Manufacturing, Quality, Regulatory, and R&D teams.
• Ensure compliance with FDA, ISO 13485, ISO 14971, and medical device design controls.
• Support manufacturing transfer, design changes, and product launch activities.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 5+ years of medical device design and development experience.
• Experience with Class II and/or Class III medical devices.
• Strong proficiency in SolidWorks or Creo.
• Hands-on experience with GD&T, DFMEA, V&V, DFM, and Design Controls.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Excellent communication, analytical, and problem-solving skills., * Experience with injection molding, machining, plastics, and metal components.
• Familiarity with IEC 60601.
• Experience supporting regulatory submissions and product commercialization.

$34 - $36 an hour - Contract