Principal Project Engineer

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader, and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946. Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a medical

practitioner designated by the Company

 As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers.  Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyse glucose levels. We are helping people with Diabetes lead healthier, happier lives. The FreeStyle Libre portfolio has been a cornerstone to Abbott’s successful business and has been developed on a platform of strong innovation throughout the organization. This role will require the successful candidate to be involved with multiple novel product and process development projects which compliment a culture of continuous improvement within Abbott Diabetes Care.  The Abbott Diabetes Care facility is supported by both local and global Engineering functions which collaborate to achieve manufacturing sustainability and implement process improvements to meet long-term business goals and evolving customer demands.

As a Principal Project Engineer, you will be responsible to:

Lead highly complex projects of introduction and optimization of best-in-class, fully automated manufacturing lines within Abbott’s Third-Party Manufacturers. The successful applicant will be responsible for the entire lifecycle of new equipment and major modifications to existing footprint from design review through to production ramp up.

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  Manage, plan, and implement and major engineering projects associated with assembly of finished product including new product development, build, test, commissioning, validation activities (IQ/OQ/PQ), RCE documentation etc. as required.

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  Drive activities at the equipment supplier(s) to ensure that production start-up through to scale up to increased volumes are achieved per ADC requirements.

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  The position provides technical leadership and project management for a team

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  Lead and participates in design, planning, introduction, and sustaining of automated manufacturing lines.

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  Ensure the project meets quality requirements of all key internal stakeholders including but not limited to internal (ADC) R&D, Regulatory, Quality groups while also being the key contact for site operations to ensuring adherence to the required ADC policies and procedures. Measures and reports progress against approved timelines.

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  Ensure prompt attention of Senior Management in areas of risk, which might have an adverse effect project delivery, product and/or safety.

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  Acts as an effective project leader in supporting timelines, quality disciplines, decisions, and practices.

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  Interface with product team members, department managers, designers/equipment manufacturers, R&D, Quality, and Regulatory personnel.

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  Represent department/division on projects.

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  Show initiative in developing and promoting implementation of innovative ideas or potential solutions and champions change without prompting. Controls and implements any relevant engineering changes.

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  Independently conceive and develop problem solving approaches which require application of advanced technical knowledge - applies working knowledge of related disciplines.

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  Independently designs and leads complex engineering studies and experiments often with multiple variables. Analyses complex problems and identifies their impact using statistical analysis of measurement results. Sets complex design and process requirements.

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  Responsible for completing documentation in a timely manner and in accordance with business standards.

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  Initial project related travel is to be expected – approximately 25%. Europe and US (primarily).

• Capability of creating process documentation and technical procedures associated with medical device processes & equipment.

• Capability of reviewing equipment design and conferring with scientific, engineering, and technical personnel to select suitable measurement methods and resolve hardware and software problems (such as product or system malfunctions, incomplete test data, data interpretation or coding issues).

• Analytical skills required to perform root cause analysis, develop and coordinate corrective action measures, and define monitoring improvements for issues affecting yield and cycle time problems.

• Capable of analysing and interpreting process characterization data and prepares technical reports for use by engineering and management personnel.

• Strong interpersonal skills for liaising between vendors, suppliers, Third Party Manufacturers, host-site personnel, management, and colleagues.

• A relevant Level 8 Degree in Engineering/Manufacturing, Science discipline, and equivalent with 5+ years progressive technical experience and demonstrated competence. Automation / Electronics / Mechatronics degree preferred.

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.

• Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.

• Ability to Multitask, prioritize, and meet deadlines in timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• The immediate reporting line will be to offsite remote manager, with onsite team-based support.  The individual will be required to be self-starting and self-motivated.

• Proven track-record of accomplishment in applying continuous improvement projects.

• Minimum 5 years of relevant experience with automated manufacturing processes preferred.

• 2+ years previous experience in a Medical Device or Pharmaceutical environment preferred.

• Experience of Project managing the implementation of high-speed automation lines in a high-volume medical device environment and new product process development preferred.

• Experience of design, commissioning, and validation lifecycles of complex automated equipment preferred.

• Knowledge and competence in development, validation, and launch of high-volume manufacturing lines for medical devices.

• Prior experience and familiarity with a cGMP, FDA, and ISO regulated environment.

• Understanding & knowledge of automated manufacturing systems, measuring technology, equipment software, pneumatics, electronics, vision systems, lasers, and GAMP guidelines.

Please note that any offer of employment is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a Company-designated medical practitioner.

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Abbott is an equal opportunities employer

In specific locations, the pay range may vary from the range posted.