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R&D Engineer – Structural Heart Device Development

CroiValve · Dublin

New
Onsite 🇬🇧 English
SolidWorks Risk management Technical documentation

Job description

About the role

We are seeking an R&D Engineer to join our team developing a cutting‑edge structural heart device. The role will focus on the design, testing and validation of the implant, delivery system and related sub‑components, supporting the product through clinical trials and regulatory approval.

Key responsibilities

  • Collaborate in a cross‑functional team to design and develop a novel transcatheter heart repair device.
  • Create detailed component drawings, specifications and peer‑reviewed documentation.
  • Use SolidWorks to review, import and optimise 3D models.
  • Develop computational models and first‑principles analyses to predict in‑vivo performance.
  • Source, build and test prototypes, analyse data and identify optimal solutions.
  • Design and execute test methods for product evaluation and validation.
  • Drive risk management for assigned components and support system‑level risk‑based design.
  • Prepare technical reports and presentations for internal and external stakeholders.
  • Generate documentation for the Product Design History File and Device Master Records.
  • Support clinical validation activities and assist with device preparation for clinical cases.

Required profile

  • Strong technical foundation in medical device development, preferably cardiovascular devices.
  • Knowledge of key materials and manufacturing processes used in medical devices.
  • Data‑driven problem‑solving mindset with experience in robust data capture and analysis.
  • Commitment to patient safety, product quality and regulatory compliance.

Required skills

  • SolidWorks (CAD)
  • Prototype testing
  • Computational modelling
  • Risk management
  • Technical documentation

What we offer

  • Opportunity to work on innovative heart‑repair technology.
  • Collaborative, multidisciplinary environment.
  • Support for continuous learning and professional development.

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Published 8 hours ago

Expires 1 month from now

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CroiValve

Dublin