Process Development Engineer

Project engineer

• • Supports the development, definition and execution of complex Process related activities such as CAD/CAM and/or CMM programing.
  • Support Acquisition and Execute Equipment installation and related validation activities
  • Responsible for the creation and execution of associated process qualification and validation activities
  • Complete capability studies for in process inspection and generate subsequent Inspection documentation.
  • Conduct MSA studies for new products and new processes.

Process Development EngineerJob Title Process Development Engineer, Advanced Operations Pilot LinePurpose of Job - Supports the definition, development and execution of Process development elements with an emphasis on the manufacturing process, technology and technical documentation required to define and specify new product manufacturing process - Partner with Engineers on the assessment and development of new manufacturing technologies and processes related to NPI and ensure their timely transfer - Shop floor and production planning activities to ensure an efficient operation of the Advanced Operations Pilot Line Key responsibilities Process Engineering - Provide Technical support for new process introductions, ensuring that all activities are completed and documented in accordance new product development procedures - Ensure quality of process and product as defined in the appropriate operation and material specifications - Partner with Project and Process Engineers on the development of manufacturing and/or inspection process flows as well as on executing DOE, DFM/DFI activities - Supports the development, definition and execution of complex Process related activities such as CAD/CAM and/or CMM programing. Support and execute the associated qualification and validation activities - Support Acquisition and Execute Equipment installation and related validation activities - Assist the selection of equipment based on analysis of specifications, reliability and regulatory requirements - Will analyze equipment to establish operating data, conduct experimental test and result analysis. Participate in process review meetings. - Complete capability studies for in process inspection and generate subsequent Inspection documentation. - Conduct MSA studies for new products and new processes. - Execute training for shop floor team members to ensure knowledge transfer into Operations - Ensure adherence to GMP and safety procedures - Creation, rework and approval of quality documents and technical reports (SOP's, FMEA, setup sheets, requirements specification Process and execute Change requests and NC/CAPA Shop Floor Management - Production planning and shop floor management (order creation and release, order prioritization, deadline monitoring) - Responsible for the availability of raw material and operating resources for Pilot Line - Responsible for tool management and ensuring the availability of tooling for all Pilot Line projects - Responsible for the (preventive) machine maintenance of all Pilot Line Equipment - Responsible to adhere to 5S and Line Clearance within AO SEL Additional Duties - All other duties as assignedCompetences - Per Finance policies and delegation of authority matrixEducation/Training - Technical education with BSc or equivalent in Mechanical Engineering or related engineering disciplineLanguages - 2+ years' work experience with significant experience in machining and metal-cuttingComputer literacy - Fluent in English and German both verbal and writtenExperience - Demonstrated ability to read and interpret complex drawings (incl. Models) and have the ability to understand geometrical dimensioning and tolerancing (incl. GD&T)Special knowledge - Extended knowledge of manufacturing processes and materials - Demonstrated ability to lay out and set-up machines and run manufacturing batch - Demonstrated ability to inspect any job assigned with the use of all standard inspection tools - Extended skills on ISO-CNC/CAD-CAM/CMM software's (depending on assignment) required. - Experience in an FDA regulated or regulated industry beneficial. - Excellent PC skills (MS Excel, Access, PowerPoint, Project)Personal attributes - Demonstrated communication and interpersonal skills, with the ability to work successfully in a cross-functional team-based environment that heavily emphasizes quality, performance, and accountability - Efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment.

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