Senior R&D Engineer – Limerick

A strong Medical Device multinational is seeking an experienced R&D Engineer to join their growing team. The ideal candidate will showcase proven experience in the medical device industry. 

Responsibilities:

  • Demonstrate knowledge of advanced system-level technology and R&D development process.
  • Demonstrate knowledge of medical product design.
  • Coordinating and influence product development across multiple disciplines.
  • Serve as a key resource to examine systems behavior issues and bring resolution for existing infusion products.
  • Provide technical support to a wide range of systems-level problems.
  • Making customers/stakeholders and their needs a primary focus of actions.
  • Developing and sustaining productive business relationships.
  • Setting high goals for personal and group accomplishment.
  • Establishing courses of action and plans to ensure that work is completed efficiently.
  • Consistently apply systems engineering techniques.

Requirements:

  • BSc. ideally in biomedical, mechatronics, mechanical, electrical, electronics, software or systems engineering.
  • 10+ years experience in the medical industry.
  • Ability to work with global collaboration.
  • Ability to support Regulatory Affairs with engineering input for design.
  • Ability to completion of risk benefit analysis documentation.
  • Ability to maintain technical risk management files for existing devices.
  • Knowledge of MDR/MDD/AIMD, global medical device/FDA regulations, ISO 14971, ISO13485, device remediation, UDI & device traceability, Sterilization, Material Biocompatibility, Clinical Trials, Agile PLM advantageous.
  • Experience in DFSS (Design for Six Sigma) knowledge.
  • Experience with formal Requirements Management tools and configuration tools advantageous.
  • Knowledge of model-based systems engineering (MBSE), design methods using SysML or UML, and modelling tools advantageous.
  • Understanding agile development methodologies and scrum practices advantageous.
    Strong technical writing skills, producing requirements specifications, risk reports, and test procedures.
  • Experience in traditional systems engineering development, architectural design and project engineering.
  • Must be authorised to work in Ireland.

Please contact Emer Moore to discuss in confidence

00353578638188

emoore@emtechrecruitment.ie 

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