Manufacturing Process Engineer

Occlutech Tıbbi Ürünler San. Ve Tic. Ltd. Şti.

Tasks and Responsibilities :

• Transfer and scale-up of new product manufacturing from R&D to commercial production
• Developing deep technical and historical knowledge of the process and product and applying it to decision-making and/or process review
• Designing and coordinating line layouts, cell concepts, and set-ups for current products and line extensions
• Developing workflow, workstation, and equipment improvement recommendations
• Driving and providing support to quality processes
• Perform cross-functional analyses (Quality, Production, etc.) to solve process-related problems which cause customer and internal rejections
• Conducting equipment and process validations, including IQ, OQ, and PQ
• Mentoring new production staff and providing training on a new process or equipment modifications
• Building a strong collaborative working relationship with a broad range of associates spanning varied disciplines and responsibilities (R&D, Quality, etc.
• Responding with urgency to process and equipment issues
• Applying Lean Manufacturing, Six Sigma principles, TPM Cost Reduction, and Value Stream Mapping to manufacturing processes
• Making analysis and studies with the plant team (Quality, Production, etc.) to solve ad process-related problems which cause customer and internal rejections
• Reporting

Requirements :

• Degree from a top-tier university in mechanical, industrial, or mechatronics engineering.
• Minimum of 2 years manufacturing engineering experience
• Experience developing and executing process and/or equipment validations
• Proven ability to prioritize, initiate, and drive projects to completion
• Demonstrated ability to apply engineering fundamentals to manufacturing process trending, improvement, and troubleshooting
• Excellent communication and networking skills
• A work style of hands-on involvement with all phases of projects
• Ability to work effectively in team situations as well as independently
• Advanced knowledge of the English language (Must)
• Skilled with MS Office (especially excel)
• Maintain a consistent quality culture
• Timely implementation of all applicable Global SOPs.
• Participation in the ISO 13485:2016 inspections carried out by the competent authority.
• Change controls Management
• Document Management
• Deviation and CAPA management
• Maintain product quality assurance
• MRP, ERP, and SAP knowledge

Skills & Experience:

• Background in the medical device (preferable) or pharmaceutical industry
• Experience in the application of Lean, Six Sigma, or other continuous improvement tools
• Knowledgeable of GMP and ISO requirements