Staff Process Engineer, Catheter
Business Unit: Ultrasound
Requisition Number: 221816
Primary Location: United States-Washington-Issaquah
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Catheter Process Engineer, Staff
Siemens is the market leader for the 2D and 3D ICE catheters in EP and Interventional Cardiology space. The business is seeking an individual to join an engineering design team responsible for developing ICE Catheters.
The successful candidate will work in a dynamic environment as part of an R&D team developing ultrasound Catheter products and advanced technologies. Responsibilities include:
· Design and develop processes and assembly methods working with tooling designers for fabrication of state of the art catheters. Emphasis on particular processes such as catheter body, packaging, plastic welding (tip fusion), adhesive processes, and support automation of Mfg process.
· Vendor management of key components and materials
· Interface with manufacturing to support DFX initiatives
· Write test protocols, lead IQ, OQ , PQ and conduct testing for Catheter design Verification. Optimize and document processes for manufacturing; transfer designs and processes to manufacturing personnel.
· Understand, set-up, use and interpret design of experiments (DOE) and statistical process control (SPC).
· Interface very closely with acoustic design engineers, clinical specialist, ME engineers and electrical design engineers to maximize performance by creating new components/processes/assembly sequences that solve the design challenges.
· Strong dexterity and ability to envision complex, multi-component structures.
· Technical responsibility for planning, organizing, and conducting technical projects within the design, fabrication, modification, and evaluation of catheter components and assembly processes.
· Prepare design and process specifications, analyses and recommendations for presentation and approval.
· Provide technical guidance to engineers and engineering technicians.
· Prepare material for ECO release.
Required Knowledge/Skills, Education, and Experience:
· BS degree in Materials, Chemical Engineering or a related science; MS preferred
· 8+ years of clean room assembled precision electromechanical device experience desirable.
· Experience in process design for complex catheter medical device
· Working knowledge of sterilization process for disposable medical device
· Working knowledge of plastics and extrusion process and parts
· Automation experience with high volume devices preferred
· Knowledge and experience with scientific injection molded and over mold parts
· Experience in designing medical equipment preferred, including reliability and compliance
· Excellent leadership, interpersonal and communication skills
· Knowledge of Six Sigma preferred
· Ability to adapt to change and work in a rapidly-changing environment
· Domestic and international travel required ( 5-10%)