Senior R&D Engineer

Senior R&D Engineer (FEA/CFD)  Job Title Senior R&D Engineer (FEA/CFD) Sector Medical Devices / Cardiovascular Technology Role This role focuses on leading simulation-driven engineering activities for the development of cardiovascular medical devices. The engineer defines and oversees FEA and CFD modelling strategies, interprets simulation outputs, and translates them into design, verification, and validation decisions. The position contributes across the full product lifecycle, including concept development, testing, and regulatory support.

The role operates within a cross-functional R&D environment supporting compliant and clinically effective device development.
Non-Negotiable Skills, Qualifications, and Experience   Bachelor’s degree or higher in Engineering, Biomedical Engineering, or a related field.
Minimum 5 years of experience in an engineering role.
Minimum 3 years of experience in the medical device industry.
Experience working on Class II or Class III medical devices.

Experience with non-linear finite element analysis (FEA).

Experience with computational fluid dynamics (CFD).
Experience working in a regulated environment.

Experience with verification and validation activities.

Experience with risk management processes in product development.

Experience with design control processes in product development.
Desirable Skills, Qualifications, and Experience   

Experience with cardiovascular or vascular medical devices.

Experience with bioresorbable polymers.

Experience with nitinol materials.

Experience with cobalt-chromium materials.
Knowledge of ISO 13485.
Knowledge of ISO 14971.
Familiarity with EU MDR regulations.
Familiarity with FDA regulatory processes.

Experience with Design of Experiments (DoE).

Experience with root cause analysis (RCA).

Experience with CAD design.

Experience with prototyping activities.
Experience supporting regulatory submissions.

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