Manufacturing Engineer

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

POSITION SUMMARY:
The Manufacturing Engineer's primary responsibility is to implement and optimize product manufacturing and maintaining compliance with FDA and other medical device standards, while also ensuring that production schedules are met. Production optimizations for the role include material cost and cycle time reductions, supply chain efficiencies as well as the detailed design activities of design, development, validation, and maintenance of manufacturing processes, tools, and verification fixtures.

ESSENTIAL JOB FUNCTIONS:

• Marshal the transfer of new products into production as part of the development team.
• Design and evaluate new and existing equipment and fixtures, specifications, layouts, test methods and standards in coordination with the Quality Policy and R&D functions.
• Generate and maintain efficient, up-to-date documentation (MPls), for the production of all sub-assemblies and keep accurate documentation of concepts, designs, and processes.
• When appropriate, contribute to facilities planning and engineering and other duties as needed by supervisor.
• Guide the development and implementation of a lean manufacturing culture of waste reduction and continual improvement.
• Encourage, enable, and implement continuous improvements from operations team members while promoting strict adherence to procedures and guidelines.
• Conform to the Quality Management System (QMS) that governs Ekso Bionics product realization by way of a defined product development cycle.
• Validation and Qualification Protocol Generation and Execution – IQ / OQ / PQ, PPQ
• Training manufacturing personnel on new and updated processes
• DFM collaboration on product designs with Engineering

POSITION REQUIREMENTS:

• At least 3-5 years of experience as a Manufacturing Engineer.
• Excellent hands-on experience and ability to work with electro-mechanical assemblies
• Experience with developing, implementing, and improving repeatable processes.
• Comfortable with modern 3D CAD systems. SolidWorks experience strongly preferred.
• Trouble shooting and problem-solving skills.
• Must be energetic, work quickly and efficiently with a high attention to detail and accuracy; able to effectively manage multiple priorities in a fast paced and dynamic environment.
• Is able and willing to change directions and do what is needed to get the job done
• Must be computer literate and proficient with all standard office equipment.
• Must have excellent verbal and written communication skills. Requires effective communication, persuasion and technical skills to develop, present and implement ideas to others.
• Statistical Analysis – Confidence Interval and Reliability, sample size selection, capability studies.

EDUCATION:

• Engineering bachelor's degree (mechanical, manufacturing, or industrial)

PHYSICAL REQUIREMENTS:

• Prolonged periods of time sitting or standing at a desk working on a computer.
• Ability to wear and operate Ekso Bionics products safely