Product Industrialization Engineer

Role & responsibilities Product Industrialization Engineer - Medical Devices Knowledge on medical product life cycle management Should understand manufacturing fundamentals Responsible for PDLM-Driven design changes at manufacturing facility and at supplier Accountable for Manufacturing-BOM and routing master data until release to shipment and their implementation Accountable for establishing inspection and test criteria for components and assemblies Evaluate NPI related engineering changes To be responsible for Engineering Change Request activities. Supplier communication to create samples for NPD parts and verify supplier reports. Create new part numbers and do FAI plans based on drawings and Purchasing Spec. Interface between manufacturer and supplier for resolving doubts and issues. Coordinate with SQE to get necessary documents from supplier to complete APQP (IRF, IND, PSW, RSL). Knowledge In Label ad IFUs gap assessment activities. Manage PCN received from manufacturer to implementation. Manage & Document Supplier initiated change request. Create and update supplier data base in PLM. Ensure suppliers meet Drawing and Regulatory requirements. Being in a part of CFT team for supplier nonconforming material investigations. To succeed in this role, you should have the following skills and experience: Completed engineering studies at university level; BE/BTech in Mechanical, Electrical, Electronics, Biomedical Engineering or equivalent stream. 2-3 years of work experience in medical device manufacturing & supplier quality related background. Knowledge in ISO 13485, ISO 15223 & ISO 14971. Expert in GDP procedures. Experience in supplier communication, Engineering Change. Knowledge of Global Medical Quality and Regulatory Standards e.g. IEC, FDA, UL, CE etc. will be an added advantage. Disciplined team worker, ability to work independently. Ability to present and articulate ideas to key stakeholders and leadership team. Excellent communication skills. Quality mindset in design and documentation.