Manufacturing Engineer
- Pune, Maharashtra
- Permanent
- Full-time
- Is catcher of PDLM subprojects from Product Industrialization Engineer for a specific technology
- To follow the good manufacturing practices (GMP).
- comprehension of DMR translation to production processes.
- Provides input for Manufacturing requirements in PDLM.
- To guide and perform PV related tests (e.g TMV, IQ, OQ & PQ) on the shop floor.
- Creates Quality Control Plan and Work Instructions
- Oversees equipment installation and supports rampup of specific processes at the site
- Gives input from factory side to the sign-off at SR milestone & project close Implements LCM design changes.
- Identifies and executes improvements in manufacturing processes, tools and equipment. This
- for quality and efficiency improvements.
- Applies lean manufacturing principles.
- Executes Capex optimization for repeat investments
- Obtains and installs repeat equipment at the site
- Initiates production escalations, executes problem solving related to Manufacturing processes, tools and equipment.
- Accountable for integrity of Masterdata.
- Identifies and executes improvements in manufacturing processes, tools and equipment. This is for quality and efficiency improvements.
- Applies lean manufacturing principles.
- Supports and applies new technologies in factories.
- Employs equipment, practices, and procedures which promote a healthy, safe, and secure work environment
- Executes the processes and standards with embedded quality into the way of working including adherence to compliance with safety, Cost regulatory- and environmental requirements as well as local laws, General Business principles and other policies.
- Initiates and oversees process technology development activities in the context of New Product Generation as well as product and solution technology roadmap.
- Ensures adherence to the applicable process for product introductions, qualifications and release
- Responsible for Manufacturing input in PDLM process focusing on DfMAT
- Initiates and executes Capex optimization for initial investments
- Is accountable for process and Manufacturing Requirements based on Product Specifications and Test Requirements from I&D
- Is accountable for the process and equipment capability that meets these Requirements
- Orchestrates design for lean manufacturing with according to inputs to PDLM workflows.
- Responsible for PDLM-driven design changes in factories and at suppliers and their implementation
- Is accountable for MF BOM and routing Master data until release to shipment and for PDLM ruled changes
- Is accountable for establishing Inspection and Test Criteria for owned components and assemblies
- Applies lean manufacturing principles
- To succeed in this role, you should have the following skills and experience.
- Bachelor's or master's degree in production, mechanical, Electrical, Electronics engineering with 8-10 years' experience.
- Knowledge of FDA and IEC Standards is a plus.
- Disciplined team worker, ability to work independently.
- Ability to present ideas and to convince project team members.
- Be structured and self-organized.
- Positive 'can do' attitude.
- Quality mindset in analysis and documentation
- Excellent communication, both verbal and written
- Preferably already verification or validation background/ experience
- Design for 6 sigma / DMAIC is preferred
- Design for manufacturing, assembly and testability.
- Understanding special Process like Brazing, Soldering, Cleaning will be added advantage
- Basic regulatory understanding about ISO 13485, ISO 14971 will be added advantages
- Supportive in CAPA analysis
- A background in Data Analytics will be preferred.
- Integrated Supply Chain Management
- Capable to solve complex mfg. process Problem.
- Master data management (system) change Management
- He/ She should be good at Logistics Fundamentals, Manufacturing Fundamentals, Master data management (system), Operational Excellence, Operational Risk
- PMI Competencies (Project Management) or Certification will be added advantage
- Good Knowledge about Procurement & Sourcing Fundamentals
- Product Innovation & Lifecycle
- He / She should have good understanding of CAPEX / OPEX
- Capable to work independently in software tools Windchill, Minitab & SAP.
- Hands-on experience on performing Process Validations, Test Method Validations and MSA Studies (Process capability studies).