An Engineer in the development team researches clinical problems, and develops product solutions/designs for a range of medical devices. Immediate areas of focus include abscess & nephrostomy drainage sets and both non-vascular and vascular access sheaths.
• Work closely with physicians and other customers to develop design solutions for clinical problems
• Gather clinical application information, identify performance requirements and user needs; perform requirements and risk analyses.
• Assess and improve predicate product design user interfaces for usability
• Lead and assist in the development and execution of product testing
• Create review and approve documentation related to design and transfer
• Coordinate cross-functionally (including with external design firms) to establish design input requirements, traceability tables, risk and hazard analyses.
• May act as lead for various project efforts, coordinating cross-functional work
• Assure that project deliverables and tasks are technically excellent and completed in a timely fashion.
• Design and coordinate execution of design verification and product, process, and method validation activities.
• Must work and interact effectively and professionally with and for others
throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communications skills
• BS in Engineering
• Experience in Class II/III medical device development andmanufacturing
• Experience using analytic skills and problem solving
• Current knowledge and application FDA 21CFR820, ISO 13485
• Preferred experience in with human factors and usability engineering standards
• Preferred experience in interfacing with users to understand clinical needs and how to translate needs into effective design solutions.
• Ability to travel 25% of the time
• Approximately 75% of the time is spent in a normal office environment requiring sitting and moving around the building, or in a "clean" environment Production setting requiring protective clothing and safety glasses
• Approximately 25% of the time is spent in travel to various hospitals, physicians’ offices and public places