Senior Manufacturing Process Engineer
Our client has created a world-class product that is advancing how medical institutions analyze and diagnose tissue samples. Our client works with one of the top hospitals in the country. They are using automation, and cutting-edge robotic and optical technology to create a revolutionary imaging and analysis device.
We are looking for a Manufacturing Engineer who will formalize the company’s production process and implement continuous improvements. You will be working with cross functional teams on troubleshooting and production issues. You will be involved in working on current and re-designing jigs and fixtures for the team.
Duties:
- Maintain up-to-date documentation of production processes, changes and improvements
- Work with engineering to create and maintain current documentation of designs, tool drawings and work instructions
- Create process maps, IQ/OQ/PQ, process implementation documentation, and create Device History Record.
- Lead production implementation procedures across multiple departments and train operators on change processes.
- Work with engineering on ECO implementation to ensure that all Engineering Change Orders are completed in a timely fashion.
- Troubleshoot assembly issues as they arise and implement corrective actions
- Develop manual assembly processes, assembly fixtures and test procedures and implement process improvements
- Review internal operational facility layouts for process improvement
- Implement corrective actions and preventive measures to enhance product quality
- Work with QA to develop jigs and fixtures to accelerate the inspection process
Qualifications:
- Minimum of bachelor’s degree in mechanical engineering, Manufacturing Engineering or related engineering field
- 7+ years’ experience working in a manufacturing/production environment with evidence of experience in manual assembly.
- Strong knowledge of production processes, quality management, and continuous improvement methodologies
- Experience in reading electrical and wiring diagrams.
- Driving projects from start to finish
- Experience triaging issues between assemblers, operators and mechanical engineering is a huge plus.
- Experience with writing assembly instructions is a HUGE PLUS
- Proficiency in using production planning and ERP systems such as NetSuite.
- Strong leadership, communication and collaboration skills
- Six-sigma training preferred
- Knowledge of ISO standards is a HUGE PLUS
