Senior Product Development Engineer at Abbott

Ballymote, County Sligo, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, NutritionIndustries

Requirements

Compliance with IS EN ISO 13485 requirements for design, validation, and change control programs
Ability to coordinate execution activities including documentation, project planning, technical reviews, verification, and approvals
Experience conducting complaint and CAPA investigations and developing remediation actions
Capability to conduct routine testing for feeds, giving sets, pumps, and competitor products
Knowledge of leading design changes or developing new products and managing the design path to market
Expertise in managing design, validation, and change control systems while maintaining regulatory compliance
Participation in and leadership of Continuous Improvement initiatives
Ability to support international service centers with documentation, training, and services
Support for TPM operations on new products and improvement projects
Proficiency in reviewing regulations and standards related to pump products and making recommendations
Experience leading plant capital projects, including project charters, business cases, technical design, scope documents, KPIs, project plans, and installation plans in line with quality, operations, and EHS requirements

Responsibilities

Maintain the design, validation, and change control programs 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 and CAPA investigations where required and develop actions to remediate
Conduct routine testing to support ongoing changes 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, and change control systems to provide focused and effective supporting procedures and documentation while maintaining regulatory compliance
Participate in and where appropriate, lead Continuous Improvement initiatives in the COE group
Support international service centers through provision of documentation, training, and other services 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 is informed of issues
Lead plant capital projects as assigned, including presentation of project charters and business case proposals
Develop project documentation including technical design, scope documents, and KPIs in accordance with corporate, division, and site requirements
Prepare project plans, working closely with key stakeholders on business needs and timing of project completion
Develop installation plans and complete scope of all project work in accordance with quality, operations, and EHS requirements

Skills

Product Development

Engineering

Medical Devices

Nutrition Products

Manufacturing

Operational Excellence

Continuous Improvement

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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