The Design Services Manufacturing Engineer will be responsible for the successful product and line support and for operation on DS projects working as manufacturing engineering support to projects t
The Design Services Manufacturing Engineer will be responsible for the successful product and line support and for operation on DS projects working as manufacturing engineering support to projects transferring to a commercial steady state production environment.
The role will involve working closely with project leaders and the manufacturing support teams to ensure new products are successfully transferred to volume production.
This position requires a candidate with medical device products and manufacturing and process development experience in the medical device arena.
Key Job Responsibilities:
- Working as part of the Design Services/Device Manufacturing groups, the successful candidate will be responsible for the following:
- Successful transfer of new products through the DS project process to volume manufacturing acting as manufacturing/process engineering and support complementing the design engineering staff on specific projects.
- Development, resourcing and execution of project plans for the transfer of products to volume manufacturing.
- Development Product, Process and Design for Manufacture skills within the new business engineering team.
- Support product development projects from a Design For Manufacture perspective
- Design/Source Equipment and Tooling required to meet both the Capability & Capacity requirements
- Implement lean manufacturing initiatives such as cell layout design based on detailed takt time analysis, identify and eliminate sources of waste activity, implement Kanban Systems and 5S Principles
- Clearly define the content and location of the Metrics Board for each manufacturing cell and train Supervisor/Operators in updating and interpreting results
- Identify and execute continuous improvement projects that improve Key Performance Indicators (KPIs)
- Present updates to management and customers regarding cell performance and continuous improvement status
- Resolve quality and technical issues such that impact on product supply to customers is minimized
- Implement maintenance procedures for critical equipment
- Define Training Requirements for Operators/Technicians in conjunction with Supervisors to facilitate Job Rotation within Cell
- Generation of Project Documentation – pFMEAs, Process Validation Protocols & Reports, Manufacturing Procedures, BOMS, Routers, etc
- Engineering degree or equivalent.
- 2+yrs (5 years preferable) industry experience in controlled manufacturing and/or process development environment.
- Knowledge of Medical Device development and manufacturing a distinct advantage.
- Have proven experience of working in controlled environments and operating to high level GMP procedures.
- Ideally would have operated on product transfers/R&D environment and is familiar with these type processes.
- Ideally will have experience in applying lean manufacturing and six sigma principles in a production environment
- Solid skills in tool design, jigs, fixturing, lean principles and practices and manufacturing flow. SolidWorks skill an advantage.
- Ideally will have validation background including IQ/OQ/PQ/PPQ and will understand statistics/DOE and be efficient operating Minitab software.