Business Unit: Ultrasound
Requisition Number: 238468
Primary Location: United States-Washington-Issaquah
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Staff Catheter Engineer, Risk Management & Verification
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. This position will primarily be responsible for leading the design verification effort and as such will own the test protocol creation for verification of ultrasound catheters single use devices.
· Own catheter risk management for new product development and legacy product sustaining. As such will interact with the compliance, development team, manufacturing and other stake holders regarding risk analysis, ECO review and approval, HRE and compliants.
· keep up of relevant standards for the single use catheter Class III device, such as biocompatibility, sterialization, packaging, labeling, and/or other catheter standards.
· Lead and drive the design verification test (DVT) for new product development and sustaining projects
· Improve the current design verification testing.
· Interaction with internal and external regulatory and compliance agencies for compliance aspects of the Ultrasound Catheter products
· Participate in development projects and interact with Manufacturing and NPI team to insure the
DFX requirements are met.
· Prepare verification / validation protocols and document and release the final report
· Conduct failure investigation involving variety of destructive and nondestructive tools.
· Ownership of the catheter requirement specification defining the reliability and compliance requirements.
Required Knowledge/Skills, Education, and Experience:
· BS in Mechanical, Industrial , Biomedical or other engineering fields
· 10+ years product development experience of single use Sterile medical device preferred Class III
· Relevant technical experience in related field such as device development and manufacturing
· knowledge risk analysis and management (e.g. FMEA ) for medical device
· Knowledge of relevant Class III medical device standards
· Experience in designing medical equipment preferred, including design verification, risk analysis, quality, reliability and compliance
· Excellent leadership, interpersonal and communication skills
· Statistical analysis - Inferential statistics; Knowledge of Six Sigma preferred
· Ability to adapt to change and work in a rapidly-changing environment
· Domestic and international travel required ( 5%)