Senior Product Development Engineer

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and products in diagnostics medical devices nutritionals and branded generic medicines. Our 114000 colleagues serve people in more than 160 countries.

Abbott in Ireland

Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics diabetes care medical devices and nutritional Ireland Abbott currently employs about 6000 people across ten sites located in Dublin Donegal Clonmel Cootehill Galway Kilkenny Longford and Sligo.

Abbott Ireland Nutrition Sligo

We understand that proper nutrition is the foundation for living the best life possible. Thats why we develop science-based nutrition products for people of all ages. Our products help babies and children grow keep bodies strong and active and support the unique nutrition needs of people with chronic illnesses to make every stage of life a healthy one.

Abbott is a leader in providing enteral nutrition feeding devices including enteral feeding pumps and pump sets. Enteral feeding (also known as tube feeding) is a means of providing nutrition to people who cannot obtain nutrition by swallowing. Enteral nutrition contains all the calories and vitamins a person needs. Over the years weve transformed from manual operations to a state-of-the-art fully automated facility. Now located in Carbury Point Finisklin Sligo our award-winning site is recognized for operational excellence safety training and community involvement. The prestigious Shingo Prize for Operational Excellence highlights our commitment to continuous improvement and a culture of excellence delivering sustainable results year after year.

Primary Function / Goals / Objectives

Reporting to the Device Technical & Innovation Manager.

Your key responsibilities include the following:

• Maintain the design validation and change control programmes in compliance with IS EN ISO 13485 requirements.

• Coordinate execution activities such as documentation requirements project planning technical reviews verification and approval activities.

• Conduct complaint & CAPA investigations where required and develop actions to remediate.

• Conduct routine testing to support ongoing change relating to feeds giving sets or pumps including competitor products.

• Lead design changes to products or develop new products and manage the design path to market.

• Manage ongoing development of the design validation change control systems to provide focused and effective supporting procedures and documentation while maintaining regulatory compliance for device products.

• Participate in and where appropriate lead Continuous Improvement initiatives in the COE group.

• Support international service centres through provision of documentation training and other services as required to ensure cost effective and compliant pump service operations.

• Support TPM operations in terms of new products and improvement projects as appropriate.

• Review and keep abreast of regulations and standards development as they relate to Abbott pump products. Make recommendations and ensure management are informed of issues.

• Responsible for leading plant capital projects as assigned.

• Presentation of project charters and business case proposals for review with management team.

• Development of project documentation including technical design scope documents and key performance indicators (KPIs) in accordance with corporate division and site requirements.

• Preparation of project plans working closely with key stakeholders on site on business needs and timing of project completion.

• Development of installation plans and completion of scope of all project work in accordance with quality operations and EHS requirements

• Presentation of project updates to Management including reporting on Accomplishments/ Upcoming Activities/ Risk & Mitigation & Key Milestones on a regular basis.

• Ability to effectively manage project communication at all levels with key stakeholders and contractors.

• Mentors employees by sharing technical expertise and providing feedback and guidance.

• Interacts cross functionally and with internal and external customers.

• Serves as a consultant for engineering or scientific interpretations and advice on significant matters

Education Required:

• Educated to Degree level in Engineering Science or related discipline including at least 5 years satisfactory experience in a technical or scientific role within a regulated environment / medical device role.

What we Offer

Attractive compensation package that includes competitive pay as well as benefits such as

• Family health insurance

• Excellent pension scheme

• Life assurance

• Career Development

• Access to many more benefits

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The base pay for this position is

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

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