R-D Engineer II - Exempt

This is an exciting opportunity to join our Structural Heart business unit and work with a dedicated team focused on the development and expansion of our new transcatheter heart valve replacement system. In this role, you will be working on the delivery system team to develop, qualify, and commercialize the device.

• Design, develop, and optimize transcatheter heart valve delivery systems.
• Develop a deep understanding of procedures through cadaver and animal studies to refine device usage and procedural aspects in partnership with physicians; provide support to clinical trials as needed.
• Generate work instructions, test methods, engineering models, and drawings / prototypes to characterize product and process specifications.
• Develop test strategy based on design requirements derived from voice of customer, and execute on protocol, testing, data analysis, and reports required for regulatory submissions.
• Identify issues, conduct root cause analysis, and map out resolution when designing parts, components, and sub-assemblies using engineering first principles and appropriate test evaluations.
• Create and update design control documents, including updating risk analysis documents, based upon technical knowledge of device and procedure.
• Develop project plans to manage the work individually and across multiple team members.

Requirements

Specialist Career Stream

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and / or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Differentiating Factors

Required Knowledge and Experience : Requires practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.