Our Lead Manufacturing Engineer develops, implements and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies and final assemblies. Your responsibilities will also include participation in design reviews, design transfer to production as it relates to development of manufacturing processes, post processing development, equipment and process validations, process definition for machine operation and maintenance requirements, test/inspection methods, fixturing, gauging and applying inspection and process control techniques.
- Lead new advanced materials science capital equipment setup activities, including preparing facilities, supporting machine installations and related commissioning activities including validations.
- Conduct process development activities, including creation of SOPs, for machine and/or equipment operation for DMLS machine and associated post processing operations.
- Perform design reviews that incorporate a detail oriented perspective on the impact of specific DMLS processes on surface finish, dimensional accuracy, and overall integrity of produced parts.
- Support implementation of manufacturing changes that require qualification and/or validation of new equipment or processes.
- Interface with suppliers on technical issues causing inefficiencies, waste or potential supply chain interruptions.
- Review designs/prints in both the development and production phases to assure effective use of DFM/DFA/DFI, and collaborate with Development/Design Engineering, Quality Engineering, QC/metrology, Programmers and machinists to create designs and drawings that can be manufactured efficiently with a high confidence of product meeting specifications.
- Develop business processes and metrics and tracking tools for deliverables the department is responsible for completing.
- Lead CAPA process for non-conforming material reports, out of tolerance reports and product complaints that result from manufacturing issues.
- Perform duties in compliance with applicable regulations and standards including FDA Quality System Regulation 21 CFR 820, ISO 13485, and the European Medical Device Directive.