NPI Engineering Lead

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

We are looking for an New Product Introduction (NPI) Team Lead to join our engineering team in Ballytivnan, Sligo. The successful candidate will provide a technical service to support and implement Medical Device New Product Introduction (NPI) including introduction of new products, technologies, processes, and materials to meet and serve the Medical Device requirements for Abbvie. You will lead and foster a team to support Medical Device NPI encompassing design, build and validation of new injection moulding tooling , equipment, materials and automation equipment and processes in accordance with all safety, regulatory and organisational requirements including schedule and budgets.

Roles and Responsibilities

• New Product Introduction - input towards design for manufacture, design trialing, debug and validation.
• New design & manufacturing processes research & process introduction.
• Project/trouble shooting/fault finding support to both internally & externally to BT as required.
• New equipment design and introduction.
• Process validation and trouble shooting.
• Knowledge transfer to wider group once processes are in place.
• Project Management from concept to conclusion.
• New technologies research and introduction to further the business.
• Process improvement initiatives on existing processes to further improve performance metrics including yield, downtime, prevention of problems recurring, etc.
• To assist with implementing upskilling of existing workforce as part of their personal development plan to ultimately raise the skill levels / skill sets within the plant.
• Advance performance of site through Key Performance Indicators and metrics.
• Partner with Operations to ensure daily production is met addressing major contributors to down time.
• Interface and work with equipment vendors as required for detailed issue resolution.
• Embrace and drive the site Maintenance Excellence Programme.
• Comply with EHS policy and procedure and embed a culture of EHS Excellence in team.

• Level 7 or higher Engineering qualification
• Minimum of 3 years in a high precision manufacturing industry post qualification
• Minimum 2 years of experience required in the regulated manufacturing environment
• Proven problem-solving ability on complex equipment
• Knowledge of commodity and engineering thermoplastics and associated processes including design and build of complex automated assembly equipment.
• Proven ability to introduce and validate complex medical device components including DQ, IQ, APCOQ, FAT, SAT, and OQ execution.
• Medical device experience with experience of plastic component associated assembly processes including ultrasonic welding
• Experience in introduction and validation of moulding ancillary equipment including robots, tote handling systems, robots, dryers and material handling equipment as well as complex automated equipment with knowledge of validation documentation suites and data security and testing requirements.
• Knowledge of cleanroom manufacturing requirements and associated health & safety requirements including CE marking.
• Proven track record leading and engineering team in adynamic environment with reporting and presentation to SLT on progress, budget and schedule.

Desirable

• Product testing experience and Statistical analysis capability
• PLC programming knowledge
• Shingo, LEAN & SMED experience
• Microsoft Project experience
• Knowledge of Maintenance Excellence

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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