Innovative Drug Delivery Systems Engineer

1 week ago


Dublin, Dublin City, Ireland beBeeMedical Full time €60,000 - €70,000

Azurity Pharmaceuticals is a pioneering specialty pharmaceutical company dedicated to delivering innovative products that cater to the needs of underserved patients. Our commitment to quality and accessibility has enabled us to establish ourselves as an industry leader in providing unique, high-quality medications that have benefited millions of patients worldwide.

We are seeking an experienced Medical Device Engineer to join our dynamic team focused on advancing cutting-edge drug delivery systems. In this role, you will collaborate with multidisciplinary teams to design and develop high-quality combination products for global markets enhancing patient outcomes around the world.

Job Overview

This is a hybrid position based in Dublin/Zug with in-office days on Tuesday Wednesday and Thursday. As a highly motivated and experienced Medical Device Engineer you will be responsible for designing and developing state-of-the-art drug delivery systems ensuring high quality standards in strict timelines and budget.

Main Responsibilities
  • Documentation: Create comprehensive documentation including Design Development and Verification Plans Design Inputs/Outputs and User Requirements Specifications (URS) Risk Management Documentation (ISO 14971) and Conformity Assessments and DHF (Design History File) management.
  • Project Execution: Develop respiratory nasal parenteral drug delivery systems with high quality standards in strict timelines and budget.
  • Regulatory Compliance: Apply regulatory standards to ensure designs meet global compliance requirements including ISO 13485 ISO 14971 21 CFR 820 and 21 CFR 820.30.
  • Communication and Collaboration: Liaise with external and internal stakeholders to gather necessary information and ensure smooth communication.
Prerequisites
  • University degree in Engineering or Biomedical or a related scientific field.
  • 5+ years of experience in drug delivery device development.
  • Proven expertise in regulated environments under cGxP QSR or equivalent.
  • In-depth knowledge of combination product regulations and industry practices.
Benefits

This role offers a unique opportunity to work with a talented team of professionals who share your passion for innovation and excellence. You will be part of a collaborative environment that values open communication and teamwork.

About Us

We are a leading player in the pharmaceutical industry dedicated to making a positive impact on people's lives. We strive to create a culture that is inclusive respectful and supportive of our employees' growth and well-being.



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