A venture-backed, clinical-stage medical device start-up who are developing a Class III device are hiring a Principal R&D Engineer in Galway.
This role will suit a highly skilled Principal R&D Engineer with extensive experience in valve design and development to lead key aspects of the product development program, reporting to VP of R&D.
Key Responsibilities
* Lead the design and development of transcatheter valve implants.
* Collaborate closely with physicians, clinical advisors, and cross-functional teams to refine product requirements and translate clinical needs into engineering specifications.
* Own design documentation including risk analysis (e.g., FMEA), design history files, and design inputs/outputs.
* Guide material selection, prototyping approaches, and manufacturing process development for the valve components.
* Serve as a technical lead and mentor for junior engineers, promoting innovation and best practices in R&D.
Qualifications
* Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field
* Minimum of 8- 10 years of medical device development experience with at least 5 years focused on heart valve design and development
* Strong interpersonal skills and ability to thrive in a fast-paced, collaborative start-up environment.
Preferred Experience
* Prior work in early-stage companies and comfort with ambiguity
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