Overview
Have you ever wanted to make a difference?
Abbott is a global healthcare leader with a portfolio spanning diagnostics, medical devices, nutritional products and branded generic medicines.
Abbott employs over 113,000 people across more than 160 countries, and operations in Ireland include over 5,000 staff across nine sites with manufacturing facilities in Clonmel, Cootehill, Donegal, Longford and Sligo, plus a third-party manufacturing management operation in Sligo.
Pre-employment medical examination, including drug and alcohol screening, is required for this position.
Abbott Diabetes Care & Global Engineering Support
As a global leader in diabetes care, Abbott is committed to high quality products and client support.
The FreeStyle Libre portfolio is a cornerstone of Abbott's business with ongoing innovation.
This role involves working on multiple product and process development projects to support continuous improvement within Abbott Diabetes Care.
The facility is supported by local and global Engineering functions to achieve manufacturing sustainability and implement process improvements aligned with long-term business goals.
What you can make a difference in
As a Principal Project Engineer, you will be responsible for leading highly complex projects for the introduction and optimization of best-in-class, fully automated manufacturing lines within Abbott's Third-Party Manufacturers.
You will manage the entire lifecycle of new equipment and major modifications from design review through production ramp up.
Key Responsibilities
Manage, plan, and implement major engineering projects for assembly of finished product including new product development, build, test, commissioning, validation activities (IQ/OQ/PQ), RCE documentation, as required.
Coordinate with equipment suppliers to ensure production start-up through scale up meets ADC requirements.
Provide technical leadership and project management for a team.
Lead and participate in design, planning, introduction, and sustaining of automated manufacturing lines.
Ensure project meets quality requirements of internal stakeholders (R&D, Regulatory, Quality) while adhering to ADC policies and procedures; monitor progress against timelines.
Highlight risks to Senior Management that could affect project delivery, product quality, or safety.
Act as an effective project leader in supporting timelines, quality disciplines, decisions, and practices.
Interface with product team members, department managers, designers/equipment manufacturers, R&D, Quality, and Regulatory personnel.
Represent department/division on projects and promote innovative ideas or solutions; drive engineering changes as needed.
Develop problem-solving approaches requiring advanced technical knowledge and cross-discipline application.
Design and lead complex engineering studies and experiments; analyze problems using statistical methods and define design and process requirements.
Complete documentation in a timely manner according to business standards.
Travel to Europe and the US is expected, approximately 25%.
You should also have the following skills
Ability to create process documentation and technical procedures for medical device processes and equipment.
Ability to review equipment design and work with scientists, engineers, and technicians to resolve measurement, data interpretation, or coding issues.
Analytical skills to perform root cause analysis, coordinate corrective actions, and monitor improvements for yield and cycle time.
Ability to analyze and interpret process characterization data and prepare technical reports for engineering and management.
Strong interpersonal skills for liaising between vendors, suppliers, third party manufacturers, site personnel, management, and colleagues.
Qualifications and Experience
A relevant Level 8 Degree in Engineering/Manufacturing, Science, or equivalent with 5+ years of progressive technical experience; automation/electronics/mechatronics degree preferred.
Ability to work in a team and as an individual contributor in a fast-paced environment; ability to engage others to accomplish projects.
Strong verbal and written communication skills for multiple levels in the organization.
Ability to multitask, prioritize, and meet deadlines.
Strong organizational and follow-up skills with attention to detail.
Reporting line to an offsite remote manager with onsite team support; self-starting and self-motivated.
Proven track record of applying continuous improvement projects.
Preferred
Minimum 5 years of relevant experience with automated manufacturing processes preferred.
2+ years of experience in a Medical Device or Pharmaceutical environment preferred.
Experience in project managing high-speed automation lines in a high-volume medical device environment and new product process development preferred.
Experience in design, commissioning, and validation lifecycles of complex automated equipment preferred.
Knowledge of development, validation, and launch of high-volume manufacturing lines for medical devices.
Familiarity with cGMP, FDA, and ISO regulated environments.
Understanding of automated manufacturing systems, measuring technology, equipment software, pneumatics, electronics, vision systems, lasers, and GAMP guidelines.
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Abbott is an equal opportunities employer
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