NPI / Production Engineer

Develop and implement NPI processes to produce all new products.
Develop documentation to support production -work instructions, flow charts, procedures, routings, and
product labels.
Updating drawings and 3D models according to production requirements in collaboration with the R&D
department.
Drive and report all assigned Product Engineering projects using tools such as Gantt, Project Status, etc.
Focusing on agreed KPIs.
Works closely with other departments during the new product development process to ensure design for
safety, testability, manufacturability, cost position, and DFX.
Interfaces, trains, and provides technical support to production personnel for the release of new products and
procedures.
Drive validation test planning to ensure there is no unexpected variation in our processes and design.
Integrates and implements electronic and mechanical prototypes and permanent test equipment in support of
new product development efforts.
Work with the cross-functional team to ensure we have a robust risk mitigation process (FMEA) and effective
process.
דרישות התפקיד
Bachelor’s degree or better in an engineering discipline required, mechanical preferred.
5+ years’ experience in an engineering or manufacturing role in a medical device and multidisciplinary.
Experience with ECO process and implantation at contract manufacturer site.
Experience in production planning, scheduling, or related manufacturing process control.
Experience in a manufacturing environment - Essential.
Experience with Priority - Preferred.
Experience with Solidwork & PDM.
Understanding of FDA, ISO, and IEC 60601 standards and regulations.
Experience of Delivering Results & Problem Solving.