The Design Engineer II will be responsible for translating business needs into technical solutions across a variety of vascular device platforms. The engineering role performs assignments involving considerable responsibility including: design of medical devices and sub-assemblies, development of product specifications, analysis of engineering problems and demonstration of design compliance through verification and validation activities. The role requires close collaboration with Customers, Marketing, Management, Engineering, Regulatory, Design Assurance, and Operations, throughout the development cycle.

RESPONSIBILITIES:

• Translation of user needs/design inputs into design requirements, part and assembly specifications

• Designing, prototyping and constructing innovative vascular access guidewires and related interventional devices

• Integrating and transferring both emerging and existing technologies and materials into guidewire technical capabilities

• Develops and documents test methods to evaluate product performance.

• Leverages ongoing development project technologies to transfer between and aligned efforts throughout the cardio and vascular division

• Reviews test procedures and plans prior to implementation, conducts failure analysis and inspection on products, processes and materials Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications

• Provides planning inputs and executes on project deliverables to meet established metrics

• Generates, reviews and approves engineering change orders. Investigates root cause for product and process failures and establishes corrective actions

• Authors technical documents including but not limited to: technical memorandums, design verifications/validations, input/output matrices, and product specifications.

EDUCATION & EXPERIENCE:

• Bachelor's degree in related Engineering field, experience in Materials Science a plus

• Minimum 3 years of experience in design, delivery system experience preferred

KNOWLEDGE & SKILLS:

• Experience with design controls, FDA/ISO regulations.

• Proficiency with mechanical CAD (SOLIDWORKS preferred).

• Demonstrated design and prototyping capabilities including FMEA, tolerance analysis, design for manufacturability (DFM) and other methods

• Demonstrated problem solving skills. Proficiency with root cause and statistical analysis tools.

• Strong written and oral communication skills. Demonstrated ability to work in a team environment.

• Ability to plan, schedule, conduct, or coordinate detailed phases of the engineering work as part of a major project or total project of moderate scope

• Identify, initiate, and drive projects to completion