Summary: The Process Development NPI Engineer is responsible for meeting deliverables to enable Manufacturing Engineering and Operations to continue with steady-state Production as well as for delivering units (beta, pre-production, etc.) as they work to complete design transfer from R&D into Production. The candidate must be capable of collaborating with cross-functional teams both onsite and remote, analyzing mechanical designs for DFM, developing assembly and test instructions for new devices, and supporting hands-on troubleshooting of complex systems in mid-to-late design stages.
ESSENTIAL DUTIES AND RESPONSIBILITIES: ? Help drive multiple complex, and ambiguous projects in the mid-to-late stages of the design process through to the later phases of manufacturing ? Analyze new and existing device designs to provide DFM feedback to R&D teams ? Develop and document work instructions for new R&D products in preparation for manufacturing ? Design, build, and validate fixtures ? Collaborate with R&D, Quality, Supply Chain, and Production to transition new devices from design stage to production ? Act as a technical lead and point of contact for the customer to translate requirements into design and process updates. ? Draft protocols for verification & validation ? Perform troubleshooting of new and existing product ? Support resolution of nonconformances and implement preventative/corrective actions ? Perform root cause analysis ? Perform process capability studies and value-add improvement projects ? Train production technicians for new product manufacturing ? Communicate clearly with program management to identify technical requirements, risks, and impacts of design changes ? Provide regular updates to internal and external stakeholders ? Mentor junior engineers and technicians
QUALIFICATION REQUIREMENTS - Fluent English 85% B2+ ? BS/MS degree in Mechanical Engineering or other Engineering field ? More than 3 years of extensive experience in product and consumable transfers (plastics, instruments, ultrasonic products, etc.). ? Understanding of controlled manufacturing process requirements ? Strong technical problem-solving skills and ability to critically review design and debug issues through root cause analysis ? Direct experience with the following manufacturing processes is highly desired: Laser Welding (specifically with plastics, or ability to transfer skillset from other materials), Ultrasonic Welding, Heat Staking (melting filters/foils onto plastic parts), Leak testing, Laser cutters, Ultrasonic cleaning ? Must be fluent with Solidworks ? Hands-on machining and prototyping experience desired ? Strong analytical, planning, and organizational skills ? Strong interpersonal and communication skills ? Self-starter with the ability to work independently and react quickly to changing priorities. ? Willing to travel up to 75% time (flexible). Travel would be to USA locations.
L-V 8am a 5pm Centro Corporativo La Lima, Cartago, Zona franca
