Business Unit: Ultrasound
Requisition Number: 243616
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 Program Manager
Siemens is the market leader for the 2D and 3D ICE catheters in Electricalphysiology space, and volumetric ICE catheter Structural Heart space. The business is seeking a key leader to join an engineering development team responsible for developing ICE Catheters. This position will primarily be responsible for the strategy and execution to maintain the current market leading catheter products.
· Own catheter risk management for product development and legacy product sustaining. As such will interact with compliance, development team, manufacturing and other stake holders regarding risk analysis, ECO review and approval, CCB review, HRE and compliants.
· Keep up of relevant standards for the single use Class III catheter device, such as biocompatibility, sterialization, packaging, labeling, and/or other catheter standards. And develop the capability if lacking by working with outside firms and resources.
· Interact with internal and external regulatory and compliance agencies for compliance aspects such as MDD recertification, MDR qualification, of existing and new catheter products
· Create Catheter Development Process, and Catether Product Life Cycle Management procedures, as a champion from engineering side. Work with quality, regualotory, engineering, manufactring, and other cross functional teams, and insure efficient and effective processes in place for Class III disposable catheter development.
· Develop overall strategy, define related projects needed, develop execution plan, to keep up with the new compliance and regulatory standards for current and new products.
· Enhance sustating capability including DVT for the catheter business by working hand in hand with manufacturing team and outside labs collaboratively. Support critical EOL projects to reduce the business risk to a minimum.
· Work with Strategic Procurement on the strategy of catheter cost productivity and critical supplier risk mitigation for high volume catheter products. Drive advanced development projects related key catheter components and/or processes towards this purpose.
· Effectively communicate strategy, project status, risk and mitigation plan, to relevant stakeholders and senior leadership.
· Participate in development projects and interact with Manufacturing and NPI team to insure the
DFX requirements are met.
· Ownership of the catheter requirement specification defining the reliability and compliance requirements.
· Conduct failure investigation involving variety of destructive and nondestructive tools.
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 in 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 V&V, risk analysis, quality, reliability and compliance
· Project planning skills, problem solving capability and results orientation
· Excellent leadership, organizational, interpersonal and communication skills as required to collaborate across the business.
· 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 (10%)