PDS&T Senior Engineer
AbbVie View all jobs
- Sligo
- Permanent
- Full-time
- Develop engineering/technical solutions for products and processes; transfer new products from late-stage development into manufacturing, support regulatory submissions and implement major line improvements.
- Develop, plan, co-ordinate and direct PDS&T aspects of projects of local scope and importance.
- Technical lead for Design Verification activities conducted within PDS&T for projects with global scope and importance for both new products and existing products.
- Participate in investigations and develop technical solutions for product functional issues and problems.
- Develop, improve or transfer of test methods for the testing of combination devices and associated subassemblies and components.
- Provide guidance and support to AbbVie and Third-Party Manufacturing sites to resolve any product functional issues and ensure that they comply with AbbVie manufacturing and design standards.
- Independently design and conduct critical experiments that further project goals.
- Implement (and may innovate or design) new experimental protocols/techniques.
- Understand the goal and maintain high proficiency in projects as well as the overall program.
- Develop and execute plans to support product changes and updates.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.
- Proficient in operating within an environment which is largely self-managed with minimal supervision
- Other activities as assigned.
- Travel requirement: up to 10%
- Level 8 bachelor's degree in Engineering discipline or an equivalent qualification plus progressive technical experience and demonstrated competence. (10+ years experience)
- Master's degree in engineering is desirable or an equivalent qualification plus progressive technical experience and demonstrated competence. (8+ years experience)
- Medical device industry preferred. (Device design controls - Design and Development Plans, Design Inputs/Outputs, Design Verification & Validation and Design Transfer.)
- Working knowledge of cGMP, ISO/FDA regulations and EU Medical Device Regulations (MDR) desired.
- Proven ability to solve complex technical issues and evaluate multiple viable solutions. `
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.