Senior Engineer I, THV Manufacturing
Summary
Oversee and optimize a medical device (THV valve) production line, troubleshoot equipment, and lead process improvements using lean manufacturing principles.
Job Title: Senior Engineer, THV Manufacturing
- Senior Engineer I, THV Manufacturing
- Senior Engineer II, THV Manufacturing
- Senior Engineer III, THV Manufacturing
Supervisor/Manager Title: Senior Global Manager, Manufacturing Engineering
Job Description Summary: Responsible for manufacturing engineering tasks associated with sustaining clinical/commercial valve (THV) production line.
Job Responsibilities:
- Provide real-time production line support, such as daily GEMBA walks, equipment troubleshooting, daily tiered meetings, material review board.
- Develop and optimize manufacturing processes to increase efficiency and quality of products, using lean manufacturing engineering principles.
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless transfer of new product/processes to manufacturing.
- Generate, analyze and summarize data to identify improvement opportunities or to determine appropriate limits and variables for product and process. Perform Corrective and Preventative Action investigations to determine root causes for identified defects and/or trends.
- Lead short-term and long-term manufacturing process improvement activities/projects.
- Support equipment, tooling, and fixture design for development and production activities.
- Document and manage non-standard manufacturing build requests from cross-functional groups (R&D, Quality) on the production line; provide manufacturing engineering support from production planning, procedure redlines, operator training, through to completion of builds.
- Perform process characterization and validation, under the guidance of a project leader or more senior engineer.
- Confront issues in a constructive manner and at an appropriate organizational level and persevere in the face of adversity.
- Make risk-based decisions to ensure identified issues are assessed and resolved in a way that support JenaValve’s commitment to product quality, regulatory compliance and product availability.