Medical Device Mechanical Engineer — Design to Production

Plastikon Industries Inc; California (MO); On-site; USD 85,000 - 120,000; Full time

Job summary

Plastikon Healthcare in Hayward, CA seeks a Mechanical Engineer to design, develop, document, test and transfer medical device components to manufacturing. You’ll work across R&D, Manufacturing, Quality, Regulatory, and Operations to solve technical challenges and move designs from development to production.

Ideal candidates have 3+ years in mechanical design, strong SolidWorks skills, GD&T knowledge, and hands-on prototyping capability.

Qualifications

• Bachelor’s degree in mechanical engineering or related field.
• 3+ years of mechanical design, product development, or manufacturing engineering experience.
• Strong proficiency with SolidWorks and detailed drawings.
• Working knowledge of GD&T, tolerance stack-ups, DFM/DFA, materials, machining, molding, and assembly processes.
• Hands-on capability with prototype development, testing, troubleshooting, and problem solving.
• Excellent written and verbal communication skills for cross‑functional collaboration.

Responsibilities

• Design and develop mechanical components, assemblies, fixtures, and tooling using SolidWorks.
• Create and maintain 3D models, detailed drawings, BOMs, GD&T, tolerances and engineering docs.
• Support product lifecycle from concept through transfer to manufacturing and sustaining engineering.
• Build and test prototypes, troubleshoot issues, and refine designs from feedback.
• Participate in design reviews, risk assessments, CAPA, and engineering change activities.
• Collaborate with suppliers and production teams on DFM/DFA, cost and manufacturability.
• Support regulated development through design controls, verification/validation, and reports.

Skills

Communication

Hands-on

Cross-functional collaboration

Education

Bachelor's degree in mechanical engineering or related field

Tools

SolidWorks

GD&T

DFM/DFA

Prototyping

Job description

Plastikon Healthcare in Hayward, CA seeks a Mechanical Engineer to design, develop, document, test and transfer medical device components to manufacturing. You’ll work across R&D, Manufacturing, Quality, Regulatory, and Operations to solve technical challenges and move designs from development to production.

Ideal candidates have 3+ years in mechanical design, strong SolidWorks skills, GD&T knowledge, and hands-on prototyping capability.