Process Development Engineer

Process Engineering
- Provide Technical support for new process introductions, ensuring that all activities are completed and documented in accordance with the 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
Demonstrated ability to read and interpret complex drawings (incl. Models) and have the ability to understand geometrical dimensioning and tolerancing (incl. GD&T)
- 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)
- 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.

Additional Duties
- All other duties as assigned