Responsible for engineering the design, development and implementation of hypothermia product(s).
· Lead technical activities related to the development of new products and the implementation of new technologies.
· Responsible for compliance with Design Control and associated SOP’s.
· Work closely with cross-functional groups, including Manufacturing, Quality, Regulatory and Marketing counterparts in executing design objectives.
· Provide leadership on the design of endovascular hypothermia products, particularly the design of catheter and delivery system.
· Establish and maintain relationships with outside suppliers, subcontractors, and technical consultants.
· BS degree in an appropriate engineering discipline or equivalent, and ten (10) years of medical device development experience. Previous engineering project experience within an R&D organization required.
· Knowledge and experience developing procedures and products in QS Regulation and ISO compliant Quality Systems.
· Knowledge of safety and operating standards for medical devices.
· Ability to work in cross-functional product development teams and to report status to management.
· Knowledge of disposable design and process verification/validation.
· Ability to propose and support new ideas and to be pro-active, creative.