Burlington, MA · Job # 8122RK
Newly created leadership opportunity for production of the next frontier of life saving products!!
Lead implementation of manufacturing improvements, provide input for equipment selection and serve as operations liaison for transfer to production and vendor relations.
- Identify, justify and implement significant data driven projects to reduce manufacturing costs
- Develop new manufacturing processes and equipment technologies to enable low cost, high quality manufacturing
- Apply lean manufacturing methods to cut product cycle time and costs
- Design and qualify new custom tooling/equipment
- Develop highly capable manufacturing processes for existing products
- Create and maintain the documentation necessary to ensure the consistent manufacture of products
- Maintain current production processes and assist in smooth transfer of new processes onto the production line.
- Develop and execute process characterization, validation and material qualification plans
- Apply fundamental engineering principles to create practical solutions to technical challenges and provide technical support across functions
- Perform root cause analysis and develop corrective and preventative actions for quality systems and production issues
- Working with R&D and PD to help transfer new products into production
- Work with suppliers to complete change requests, risk mitigation projects and supplier related cost savings initiatives.
- Bachelor's degree in Biomedical Engineering, Material or Mechanical Engineering or similar field.
- 3+ years of experience in Manufacturing of medical devices.
- Experience with equipment and tooling design and validation
- Experience developing innovative new processing technologies
- Understanding of design and process FMECA, process validation and variability reduction applications.
- Test protocol generation, execution and reporting