The Opportunity
This position works out of our Minnetonka, MN location, supporting our EP division.
In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
As the Senior Process Development Engineer, you will perform analyses to develop process technologies and process specifications based on product design and performance requirements.
Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning.
Selects techniques to solve problems and make sound design recommendations.
What You’ll Work On
Develop processes based on product specifications and in consideration to process and test method capabilities.
Evaluate process and propose design alternatives based on Design for Manufacturability (DFM) principles.
Understand principles of Cost of Goods Sold (COGS) relative to material, direct labor, and overhead costs as well as in consideration to manufacturing process yields.
Execution Process Validations including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ)
Understand Intellectual Property (IP) issues relative to processes being developed.
Maintain knowledge of new developments in manufacturing and design technologies.
Understand work environment issues (i.e. OSHA regulations, etc.).
May supervise or provide work direction to other engineers and technicians
May lead or serve as member on cross-functional project teams
Required Qualifications
B.S. in engineering
5+ years experience in process development or manufacturing process engineering
Experience developing and validating medical device manufacturing processes and technologies with an emphasis on design for manufacturability (DFM) preferred.
Preferred Qualifications
MS in engineering
Background in Stent/Frame processing
Use of Design of Experiments (DOE) in process optimization
Background in heat treatment of metals
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