Senior Technical Specialist

3 days ago

Limerick, Limerick, Ireland beBeeSystems Full time €80,000 - €100,000
Job Title: Senior Systems Engineer

As a seasoned professional in systems engineering, you will play a pivotal role in the development of cutting-edge medical technologies by integrating hardware, software, and fluidics in regulated clinical environments.

Key Responsibilities:
  • Lead complex systems engineering activities for electro-mechanical medical device platforms.
  • Translate user needs and clinical requirements into system-level specifications.
  • Define and manage requirements traceability, risk analysis, and design inputs/outputs.
  • Collaborate with cross-functional teams to ensure integrated product development.
  • Support design verification and validation, including test planning and execution.
  • Ensure compliance with FDA 21 CFR Part 820 and ISO 13485 standards.
  • Participate in design reviews, FMEA, and hazard analysis.
  • Provide technical leadership and mentorship to junior engineers.
Ideal Candidate Profile:
  • Proven experience in medical device systems engineering, preferably with electro-mechanical or drug delivery systems.
  • Strong understanding of embedded software, fluidics, and hardware integration.
  • Familiarity with design controls, risk management, and regulatory compliance.
  • Excellent communication and documentation skills.
  • Ability to work independently and collaboratively in a fast-paced, regulated environment.
Preferred Qualifications:
  • Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Electrical/Mechanical Engineering, or related field.
  • 5+ years of experience in medical device product development.
  • Experience with tools such as DOORS, Jama, or equivalent for requirements management.
  • Knowledge of IEC 62304 and human factors engineering is a plus.

This role demands strong technical expertise, excellent communication skills, and the ability to work collaboratively in a fast-paced environment. If you have experience in medical device systems engineering and are looking for a challenging role, please apply.

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