Med Tech Mechanical Engineer

Job Title: Med Tech Mechanical Engineer
Location: Palo Alto, CA (Onsite)
 

Job Description:

Required Qualifications:

• 5+ years of Mechanical Engineering experience in the Medical Device/MedTech industry
• Strong experience in mechanical design, product development, and prototyping
• Proficiency with CAD tools such as SolidWorks, Creo, CATIA, or equivalent
• Strong understanding of GD&T, tolerance stack-up analysis, and engineering drawings
• Experience with Design Verification & Validation (DV/V), Design Controls, Risk Management, and FMEA
• Knowledge of FDA regulations, ISO 13485, and medical device quality systems
• Experience with DFM/DFA, injection molding, plastics, machining, and manufacturing processes
• Experience supporting ECO/ECN activities and sustaining engineering
• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field

Preferred Qualifications:

• Experience with Class II/Class III Medical Devices
• Knowledge of DHF, DMR, and FDA submission documentation
• Experience with medical-grade plastics, disposable medical devices, implants, surgical products, robotics, or wearable medical devices