Manufacturing Engineer - Lean MedTech Process Innovator

Valid8 Financial, Inc.; San Rafael (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Ekso Bionics is seeking a Manufacturing Engineer to implement and optimize manufacturing processes for medical devices, ensuring FDA/compliance standards and on-time production schedules. You will work on process design, validation, documentation, and collaboration with R&D to enable scalable production.

The role requires 3–5 years of experience with electro-mechanical assemblies, proficiency in SolidWorks, and strong problem-solving and communication skills.

Qualifications

• 3–5 years of experience as a Manufacturing Engineer.
• Hands-on experience with electro-mechanical assemblies.
• Develop and improve repeatable manufacturing processes.
• Proficient with 3D CAD; SolidWorks preferred.
• Strong troubleshooting and problem-solving abilities.
• Excellent verbal and written communication skills.
• Knowledge of statistical analysis methods.

Responsibilities

• Transfer new products into production as part of the development team.
• Design and evaluate equipment, fixtures, layouts, and test methods.
• Maintain documentation for production of sub-assemblies (MPls).
• Contribute to facilities planning and engineering as needed.
• Lead lean manufacturing initiatives and waste reduction.
• Drive continuous improvements with operations while following procedures.
• Adhere to the Quality Management System (QMS) per product lifecycle.
• Generate/execute IQ/OQ/PQ/PPQ validation protocols.
• Train manufacturing personnel on new processes.
• Collaborate on DFM with Engineering.

Skills

Manufacturing experience

Electro-mechanical assemblies

Lean manufacturing

Statistical analysis

Problem solving

Communication skills

Education

Bachelor's degree in mechanical manufacturing or industrial engineering

Tools

SolidWorks

Job description

Ekso Bionics is seeking a Manufacturing Engineer to implement and optimize manufacturing processes for medical devices, ensuring FDA/compliance standards and on-time production schedules. You will work on process design, validation, documentation, and collaboration with R&D to enable scalable production.

The role requires 3–5 years of experience with electro-mechanical assemblies, proficiency in SolidWorks, and strong problem-solving and communication skills.