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
