Overview In this role you will optimize and transition manufacturing processes for cardiovascular devices, using engineering methods to improve efficiency and design equipment. You will work cross-functionally with operations, sales, and quality teams to ensure smooth product transfer and production readiness. The position involves designing and executing validation experiments, solving manufacturing and compliance issues, and developing training materials for production. You will lead project plans and mentor technicians, contributing to safer, high-quality medical devices for patients. This role offers meaningful impact in a mission-driven THV program that aims to improve patient outcomes worldwide
Responsibilities- Optimize manufacturing processes using Six Sigma and LEAN techniques to improve efficiency and equipment design
- Develop moderately complex experiments and tests to qualify and validate manufacturing processes; analyze results and prepare reports
- Analyze and resolve manufacturing and compliance issues (CAPA, non-conformances, audit observations)
- Create training and documentation materials (work instructions) for production and knowledge transfer
- Establish project plans with defined deliverables using project management tools (e.g., Project Plan, Risk Analysis)
- Oversee manufacturing support tasks, guide technicians on testing, train and provide feedback
- Coordinate technician work and ensure production readiness and smooth transitions of new products
- Perform other duties as assigned by Leadership
Key requirements- Bachelor's Degree in Engineering or Scientific field with 2 years of related experience or Master's Degree or equivalent with relevant internship/ projects
- communication (written and verbal)
- interpersonal relationship skills
- problem-solving
- Six Sigma/LEAN for process improvement
- process validations
- MS Office Suite including MS Project
