Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Job description:
We are seeking an experienced Medical Device Engineer to join our dynamic team, dedicated to advancing cutting-edge drug delivery systems. In this role, you will collaborate with multidisciplinary teams to design and develop high-quality combination products for US/EU/International markets that enhance patient outcomes around the world.
Key Responsibilities:
- Documentation: Author and maintain comprehensive documentation, including:
- Design Development and Verification Plans
- Design Inputs/Outputs and User Requirements Specifications (URS)
- Risk Management Documentation (ISO 14971)
- Conformity Assessments and DHF (Design History File) management
- Project Execution: Successfully develop state-of-the-art drug delivery systems (e.g. respiratory, nasal, parenteral) 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.
- Owner of the section related to Container-Closure-System and drug-product characterisation of regulatory submissions.
- Communication and Collaboration:
- Liaise with external and internal stakeholders to gather necessary information and ensure smooth communication.
- Work closely with R&D, Legal, Quality, Regulatory, and manufacturing teams throughout development and coordinate necessary approvals.
- Lead third parties for development and commercial supply:
- Choose external vendors based on expertise, timelines, and cost, while negotiating quotes, service agreements and contracts.
- Develop components using soft and/or multi-cavity tools and validate processes while introducing acceptance testing for individual and assembled parts.
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.
- Knowledge of drug delivery devices (respiratory, nasal, parenteral), risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes, transportation studies, and validation.
- Experience with Health Authority interactions is a plus.
- A working knowledge and practical experience with device development and manufacturing operations activities for drug/device systems in a cGMP environment.
- Skills:
- Strong organizational skills with attention to detail.
- Excellent written (documents) and verbal (i.e. presentations) communication.
- Proficiency in CAD, CFD, FEA, X-ray/CT scan
- Ability to work independently and as part of a team.
Why Join Us:
- Opportunity to work with a leading pharmaceutical company.
- Collaborative and supportive work environment.
- Competitive salary and benefits package.
- Career growth and development opportunities.
Work Schedule:
- Hybrid position based in Dublin/Zug with in-office days on Tuesday, Wednesday, and Thursday.
If you are a highly motivated and experienced Medical Device Engineer looking to make a significant impact, we encourage you to apply.
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