חזרה ללוח
NPI / Manufacturing Engineer
חברה דיסקרטית
מיקום
שרון
תחום
מכשור רפואי
בכירות
ביניים
היקף משרה
משרה מלאה
גודל חברה
גדולה (200+)
סוג תפקיד
איכות
תיאור המשרה
MESH Executive Solutions is proud to partner with a global pioneer in endovascular treatment and Class III medical device manufacturing to recruit a NPI / Manufacturing Engineer for its Israeli site in Herzliya .
Position Overview
The NPI / Manufacturing Engineer will lead the development, implementation, validation, and continuous improvement of manufacturing processes for class III medical devices and implants. The role includes production support, process and equipment development, fixture design, preparation of technical drawings, process validation, troubleshooting, and implementation of engineering improvements.
The position requires close collaboration with R&D, Production, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, and external suppliers.
Responsibilities
· Develop, implement, optimize, and maintain manufacturing and assembly processes for medical devices and implants.
· Design and develop fixtures, jigs, tools, and manufacturing aids to support production and inspection processes.
· Prepare detailed technical drawings and manufacturing documentation for medical implants, components, fixtures, and tools in accordance with applicable standards.
· Use advanced CAD tools, primarily SolidWorks, for product, tooling, fixture, and process-support design.
· Define process parameters, operating ranges, acceptance criteria, and in-process controls.
· Provide hands-on engineering support to production and resolve technical issues affecting product quality, yield, capacity, or delivery.
· Investigate process failures, deviations, nonconformities, and recurring production problems.
· Identify and implement improvements in process robustness, repeatability, yield, cycle time, ergonomics, cost, and production efficiency.
· Support new product introduction, design transfer, production scale-up, and manufacturing-readiness activities.
· Support supplier qualification, process transfer, and manufacturing activities performed by subcontractors and external manufacturing partners.
· Work with suppliers to improve process robustness, manufacturing capacity, scalability, quality, and delivery performance.
· Lead cross-functional engineering projects from planning through implementation.
Qualifications
· Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
· At least 5 years of experience in manufacturing engineering, NPI, mechanical design, or industrialization.
· At least 3 years of experience in mechanical design and preparation of detailed technical drawings.
· Demonstrated experience designing fixtures, jigs, tools, or production equipment.
· Strong experience using CAD software, preferably SolidWorks.
· Experience developing, implementing, and validating manufacturing processes.
· Experience with production support, troubleshooting, root-cause analysis, and implementation of corrective actions.
· Ability to prepare clear, accurate, and controlled technical and manufacturing documentation.
· Ability to independently manage multiple projects and priorities.
· Hands-on approach and willingness to work directly with production personnel, equipment, tooling, and products.
· Strong teamwork, creativity, initiative, and interpersonal communication skills.
· High-level written and spoken English.
Preferred Qualifications
· Experience in the medical-device industry.
· Experience with Class III, implantable, catheter-based, or other complex medical devices.
· Experience working in an ISO 13485-compliant quality system.
· Familiarity with FDA and European medical-device regulatory requirements.
· Experience with design transfer, NPI, manufacturing scale-up, and process validation.
· Experience with cleanroom manufacturing and controlled-environment processes.
· Experience with manual assembly, suturing, bonding, welding, crimping, heat treatment, cleaning, or packaging processes.
· Experience working with external manufacturers and international suppliers
דרישות התפקיד
Responsibilities
· Develop, implement, optimize, and maintain manufacturing and assembly processes for medical devices and implants.
· Design and develop fixtures, jigs, tools, and manufacturing aids to support production and inspection processes.
· Prepare detailed technical drawings and manufacturing documentation for medical implants, components, fixtures, and tools in accordance with applicable standards.
· Use advanced CAD tools, primarily SolidWorks, for product, tooling, fixture, and process-support design.
· Define process parameters, operating ranges, acceptance criteria, and in-process controls.
· Provide hands-on engineering support to production and resolve technical issues affecting product quality, yield, capacity, or delivery.
· Investigate process failures, deviations, nonconformities, and recurring production problems.
· Identify and implement improvements in process robustness, repeatability, yield, cycle time, ergonomics, cost, and production efficiency.
· Support new product introduction, design transfer, production scale-up, and manufacturing-readiness activities.
· Support supplier qualification, process transfer, and manufacturing activities performed by subcontractors and external manufacturing partners.
· Work with suppliers to improve process robustness, manufacturing capacity, scalability, quality, and delivery performance.
· Lead cross-functional engineering projects from planning through implementation.
Qualifications
· Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
· At least 5 years of experience in manufacturing engineering, NPI, mechanical design, or industrialization.
· At least 3 years of experience in mechanical design and preparation of detailed technical drawings.
· Demonstrated experience designing fixtures, jigs, tools, or production equipment.
· Strong experience using CAD software, preferably SolidWorks.
· Experience developing, implementing, and validating manufacturing processes.
· Experience with production support, troubleshooting, root-cause analysis, and implementation of corrective actions.
· Ability to prepare clear, accurate, and controlled technical and manufacturing documentation.
· Ability to independently manage multiple projects and priorities.
· Hands-on approach and willingness to work directly with production personnel, equipment, tooling, and products.
· Strong teamwork, creativity, initiative, and interpersonal communication skills.
· High-level written and spoken English.
Preferred Qualifications
· Experience in the medical-device industry.
· Experience with Class III, implantable, catheter-based, or other complex medical devices.
· Experience working in an ISO 13485-compliant quality system.
· Familiarity with FDA and European medical-device regulatory requirements.
· Experience with design transfer, NPI, manufacturing scale-up, and process validation.
· Experience with cleanroom manufacturing and controlled-environment processes.
· Experience with manual assembly, suturing, bonding, welding, crimping, heat treatment, cleaning, or packaging processes.
· Experience working with external manufacturers and international suppliers
על ענף התעשייה: מכשור רפואי
תחום המכשור הרפואי (Medical Devices) עוסק בפיתוח וייצור של מכשירים, אביזרים ותוכנות המשמשים לאבחון, ניטור, טיפול או מניעה של מצבים רפואיים שונים. התעשייה משלבת בין עולמות ההנדסה, הפיזיקה, הביולוגיה והרפואה הקלינית, ומגוון המוצרים נע בין מזרקים פשוטים ואביזרים כירורגיים ועד למערכות הדמיה מתוחכמות, שתלים חכמים ורובוטיקה רפואית. בישראל קיים אקו-סיסטם ייחודי ומוביל של חדשנות בתחום זה.
מודעה
מודעה
