The Manufacturing Engineer will be responsible for the support and troubleshooting of manufacturing floor, processes and assembly with direct participation in managing CIs, quality issues investigations NMRs in order to ensure full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements. Perform work in adherence to the CMD Quality Management System (QMS), including development and maintenance of documentation.
- Support the troubleshooting of equipment and manufacturing processes
- Develop bills of materials and assembly methods, update work instructions and provide any needed training to technicians and assemblers related to processes and equipment
- Work in a cross-functional environment partnering with RD and Quality departments in order to deliver product that meets customer requirements, on time delivery and quoted price.
- Create tooling and fixtures to improve the manufacturing processes and ease the operators job in the assembly area
- Support and execute CI projects in order to reduce the cost and improve yields in the production area.
- Working knowledge of manufacturing processes related to catheter manufacturing
- Provide technical support for NMRs and customer complains investigations, performing root cause analysis, data retrieval and tests needed and required by customers or other project related issues
- Participates in the execution of protocols for Qualifications, Validations, Verification and Validation testing, and Process FMEAs.
- Actively participate in all Lean manufacturing events and initiatives taking place on manufacturing floor.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- 1 to 3 years in a catheter manufacturing environment, with exposure to product design and Fixture design.
- A working Knowledge of catheter assembly manufacturing processes.
- Demonstrated excellent written and oral communication skills.
- High School Diploma or GED required
- Bachelor’s degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
- Understanding of Lean principles and basic Lean Tools
- Experience with design controls, FDA regulation, GMP practices, and QSR requirements
- Short-term disability