Mechanical Engineer

Position Summary

Plastikon Healthcare is seeking a self-motivated, proactive Mechanical Engineer to support the design, development, documentation, testing, manufacturing transfer, and sustaining engineering of medical devices and related components at our facility located in Hayward, California. This role is ideal for a hands-on engineer who can turn concepts into production-ready designs that are safe, reliable, manufacturable, and well documented. You will partner across R&D, Manufacturing, Quality, Regulatory, and Operations to solve technical challenges, support product and process improvements, and help move designs successfully from development through production.

Key Responsibilities

• Design and develop mechanical components, assemblies, fixtures, and tooling using SolidWorks.
• Create and maintain 3D models, detailed manufacturing drawings, bills of materials, GD&T, tolerance analyses, and engineering documentation.
• Support the product lifecycle from concept through transfer to manufacturing and sustaining engineering.
• Build and test prototypes, troubleshoot issues, and refine designs based on testing and manufacturing feedback.
• Participate in design reviews, risk assessments, root-cause investigations, CAPA, and engineering change activities.
• Collaborate with suppliers, machinists, technicians, and manufacturing teams on DFM/DFA, cost, quality, and manufacturability.
• Support regulated development through design controls, verification and validation, technical reports, work instructions, and related documentation.

Required Qualifications

• Education: Bachelor’s degree in mechanical engineering or a related field.
• Experience: 3+ years of mechanical design, product development, or manufacturing engineering experience.
• SolidWorks: Strong proficiency with parts, assemblies, detailed drawings, configurations, and design documentation.
• Engineering fundamentals: Working knowledge of GD&T, tolerance stack-ups, DFM/DFA, materials, machining, molding, and assembly processes.
• Hands-on capability: Experience with prototype development, testing, troubleshooting, and technical problem solving.
• Communication: Excellent written and verbal communication skills, with the ability to collaborate effectively across functions.
• Working style: Self-motivated, proactive, organized, accountable, and able to manage multiple priorities.

Preferred Qualifications

• Experience in medical-device design, development, or manufacturing.
• Familiarity with FDA or other regulated product-development practices, GMP, ISO 13485, design controls, verification and validation, and CAPA.
• Experience working with suppliers, designing fixtures, or supporting production equipment.

Equal Opportunity - We are committed to providing an inclusive workplace and equal employment opportunity to all qualified applicants. Employment decisions are made without regard to legally protected characteristics under applicable law.