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Skills: Process Engineering, Validation (IQ/OQ/PQ), CAPA, PFMEA, NPI
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Senior
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Full-time
bachelor degree
Posted 16d ago
~40 hrs/week
Responsibilities
The Process Engineer is responsible for managing 3DP materials manufacturing processes and ensuring compliance with FDA, MDR, and ISO 13485 standards. Key duties include leading validation activities, managing CAPAs, and transferring new products from R&D to manufacturing.
Requirements
A B.Sc. in Chemical or Materials Engineering and at least 3 years of experience in a regulated manufacturing environment are mandatory. Candidates must have experience in manufacturing technology, project leadership, and strong English communication skills.
Full job description
Stratasys is a world leader in 3D printing!
Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.
Process Engineer
As part of this role, you will:
Process engineering activities for 3DP materials ensuring compliance with FDA, MDR, ISO 13485, and internal quality standards.
Own and continuously improve 3DP materials manufacturing, filling, packaging processes, and supporting production processes to enhance quality, efficiency, and reliability.
Lead root cause investigations and implement effective corrective and preventive actions (CAPA) for production deviations, quality events, and customer complaints.
Lead cross-functional engineering projects from initiation through completion, ensuring delivery within defined scope, timeline, budget, and quality requirements.
Lead validation activities including PFMEA, IQ, OQ, PQ, cleaning validation, process validation, equipment qualification, and computerized system validation.
Transfer new products from R&D to manufacturing and support process scale-up through NPI activities.
Create and maintain manufacturing documentation, work instructions, BOMs, process documentation, fixtures, and tooling required for production.
Manage external vendors and contractors during equipment installation, qualification, maintenance, and improvement projects.
Support internal and external audits by providing engineering expertise and technical documentation.
Work closely with Maintenance and Operations teams to improve equipment reliability and Overall Equipment Effectiveness (OEE).
*The position is in Kiryat Gat
Essential Education, Skills, and Experience:
B.Sc. degree in Chemical Engineering, Materials Engineering– mandatory.
Minimum 3 years of experience as a Process/Manufacturing/Production Engineer in a regulated manufacturing environment – mandatory.
Experience with validation process- IQ, OQ, and PQ (cleaning, methods, process, equipment, and software) – an advantage
Strong written and verbal English language communication skills - mandatory
Experience in manufacturing technology activities – new line establishment ,process optimization, industrial equipment, milling/grinding process, automation lines HMI, etc. – mandatory
Experience leading engineering projects from concept to implementation - mandatory
Knowledge of statistical tools, process capability, SPC, and problem-solving methodologies (8D, DMAIC, Fishbone, 5 Why) – an advantage.
Experience with Lean Manufacturing / Six Sigma / Continuous Improvement - an advantage
Ability to present technical information and effectively communicate across all levels of the organization.
Good communication skills. Team player and able to build and maintain relationships with both internal and external departments.
Familiar with control software, ERP, and Agile systems-- an advantage.
Related keywords
3D PrintingAdditive ManufacturingFDAMDRISO 13485CAPAPFMEAIQOQPQNPIBOMOEEChemical EngineeringMaterials EngineeringLean Manufacturing
Stratasys develops industrial grade additive solutions to help you solve critical design and manufacturing challenges, right along your production cycle. Working with you to push the boundaries of what’s possible. And thrive in a changing world. Make additive work for you™.
Offices: 1 Holtzman St. Science Park, Rehovot, 7612401, IL · 5995 Opus Pkwy, Minnetonka, Minnesota 55343, US · 6855 Shady Oak Rd, Eden Prairie, Minnesota 55344, US · Rua Araguari, 817, 4o. andar, sala 46, Vila Uberabinha São Paulo, SP, BR · Airport Boulevard B 120, Rheinmünster, 77836, DE
3D printingrapid prototypingfused deposition modeling (FDM)Additive Manufacturingcarbon fiberPolyJetSAFP3Stereolithography3D Printer
How many Engineering jobs are open in Kiryat Gat, Israel right now?
There are currently 33 open engineering positions in Kiryat Gat, Israel listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Kiryat Gat, Israel?
Companies currently hiring include Nestlé, Intel, Stratasys, Exyte Central Europe GmbH, JLL, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Kiryat Gat, Israel?
Yes — 3 of the 33 open engineering positions offer remote or hybrid work (0 remote, 3 hybrid).
How do I apply for Engineering jobs in Kiryat Gat, Israel?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.