Manufacturing Engineer

Ekso Bionics, Inc.; San Rafael (CA); On-site; USD 85,000 - 130,000; Full time

Job summary

Ekso Bionics, Inc. in California seeks a Manufacturing Engineer to implement and optimize production while ensuring FDA and medical device compliance.

The role focuses on reducing material costs and cycle times, improving supply chain efficiency, and supporting design, development, validation, and maintenance of manufacturing processes and fixtures. You will transfer new products to production, design equipment and fixtures, create essential documentation, and uphold a lean manufacturing

Qualifications

• 3–5 years of experience as a Manufacturing Engineer.
• Hands-on experience with electro-mechanical assemblies.
• Experience developing, implementing, and improving repeatable processes.
• Comfortable with modern 3D CAD systems; SolidWorks strongly preferred.

Responsibilities

• Marshal the transfer of new products into production as part of the development team.
• Design and evaluate equipment, fixtures, layouts, test methods and standards with R&D and Quality functions.
• Generate and maintain up-to-date documentation for production of all sub-assemblies (MPls).
• Contribute to facilities planning and other duties as needed.
• Lead lean manufacturing initiatives to reduce waste and promote continuous improvement.
• Ensure adherence to Quality Management System (QMS) throughout product realization; IQ/OQ/PQ/PPQ.
• Train manufacturing personnel on new and updated processes.
• Collaborate on DFM with Engineering.

Skills

Lean manufacturing

Electro-mechanical assemblies

Problem-solving

Communication

Documentation

Education

Engineering bachelor’s degree (mechanical, manufacturing, or industrial)

Tools

SolidWorks

3D CAD systems

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