We are looking for a compliance engineer for a 4 months engagement. This individual must be onsite in Limerick, Ireland 2 days a week.

Responsibilities:

• Take point on line-by-line assessment of standards requirements vs the product requirements and applicable evidence for client infusion products
• Responsible for assigning actions, reviewing compliance tools for completeness and appropriateness of referenced information
• Documenting the status at a regular cadence of the compliance assessment and compliance actions
• Design, lead and/or provide direction for IEC 60601 compliance testing
• Perform gap analysis in areas such as quality systems and risk management
• Participate in risk management activities
• Assess or create requirements traceability matrices
• Support or recommend remediation activities based on a strong background in quality management systems and regulatory compliance
• Create, evaluate, maintain and/or update the DHF and/or applicable portions of regulatory submissions
• Recommend remediation activities

Requirements:

• BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical/scientific discipline, preferred. 
• Electromechanical Medical Device background, Infusion pumps is advantageous
• Experience with 60601, 62304, 62366, 62133, 14971.
• 60601-2-24 experience is advantageous
• Experience with MDR
• Experience coordinating and implementing product testing at external test laboratories
• Experience with identifying requirements for compliance test plan
• Background in Electrical/Electronic or Mechanical preferred.