Systems Engineer (Medical Devices) – Limerick

A fantastic opportunity for a Systems Engineer with a strong history in medical device design and regulatory compliance.

Responsibilities:

  • Demonstrate knowledge of advanced system-level medical device technology and R&D development process.
  • Demonstrate detailed knowledge of medical product design process.
  • Coordinating and influence product development across multiple disciplines.
  • Serve as a key resource to examine product behavior issues and bring to resolution.
  • Provide technical support to a wide range of engineering problems.
  • Assures deep technical understanding of infusion products.
  • Drive technical excellence and design decisions throughout the organization.
  • Identify technical risks early and establish mitigation options and track resolution.
  • 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.

Requirements:

  • BSc. in biomedical, mechatronics, mechanical, electrical, electronics, software or systems engineering.
  • 5+ years’ overall experience in the medical industry.
  • Ability to support Regulatory Affairs with engineering input for design.
  • Completion of risk benefit analysis documentation.
  • Maintain technical risk management files for existing devices and take input from Clinical Evidence Reports.
  • Knowledge of MDR/MDD/AIMD, global medical device/FDA regulations, ISO 14971, ISO 13485, EN/IEC 60601, device remediation, UDI & device traceability, Sterilization, Material Biocompatibility, and Clinical Trials advantageous.
  • Experience working within formal medical QMS processes and system tools advantageous.
  • Experience in DFSS (Design for Six Sigma) advantageous.
  • Experience with formal Requirements Management and document configuration tools advantageous.
  • Strong technical writing skills, producing requirements specifications, risk reports, and test procedures.
  • Must be authorised to work in Ireland.

Please contact Emer Moore to discuss in confidence

00353578638188

emoore@emtechrecruitment.ie 

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