Job DescriptionWe 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 ResponsibilitiesNew 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.QualificationsLevel 7 or higher Engineering qualificationMinimum of 3 years in a high precision manufacturing industry post qualificationMinimum 2 years of experience required in the regulated manufacturing environmentProven problem-solving ability on complex equipmentKnowledge 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 weldingExperience 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 capabilityPLC programming knowledgeShingo, LEAN & SMED experienceMicrosoft Project experienceKnowledge of Maintenance ExcellenceAdditional InformationAbbVie 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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