PDS&T Senior Engineer

We are looking for a PDS&T Senior Engineer to join our Product Development Science and Technology (PDS&T) Team in Sligo. This position reports to the Associate Director PDS&T Combination Products Aesthetics & Devices (CAD).  PDS&T CAD support multiple devices such as catheters autoinjectors syringes pumps and many other this role the successful candidate will participate in relevant PDS&T projects that require a level of leadership technical competency and excellent communication skills to drive solutions across multiple sites. To be successful you need the ability to collaborate across multiple sites and apply your engineering knowledge to complete complex assignments as required in line with the strategic requirements of Product Development Science and Technology.

Roles and Responsibilities

• 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%

Qualifications :

• Level 8 bachelors degree in Engineering discipline or an equivalent qualification plus progressive technical experience and demonstrated competence. (10 years experience)
• Masters 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.

Additional Information :

Travel requirement: up to 10%

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time