What are the responsibilities and job description for the Senior Process Development Engineer position at Abbott?
The Opportunity
This position works out of our Santa Clara, CA location in the Structural Heart.
What You’ll Work On
- This position will lead studies to develop and optimize processes to improve quality and manufacturability for delivery systems.
- Run design of experiments (DOE) studies to characterize processes to improve yield and efficiency
- Coach, mentor, and provide guidance to other engineers, technicians, trainers, and manufacturing personnel.sewing specialists
- Supports Training Certification Program. Provides additional insight on how to improve trainings and certifications in the best interest of the business.
- Responsible for execution of line related change management (material, equipment and process changes). Responsible for CO & CR generation related to moderate to complex changes impacting the manufacturing line.
- Manage projects which include new production equipment, process development / improvements and cost reductions while supporting new product introductions
- Conduct process FMEAs and process validations
- Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts and root cause investigation tools (e.g. DMAIC)
- Coordinate the design, procurement, build, and debug of tooling, machinery, and test equipment
- Work cross functionally with R&D, Finance, Quality and Operations to define process inputs and outputs
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Leads root cause analysis efforts utilizing DMAIC model and A3s. Leads CAPA investigations with data gathering and analysis as needed. Owns CAPA activities without oversight
What You'll Bring :
Preferred Qualifications :
