Job Description Summary

Graduate quality engineer will work under the guidance of the Senior Quality Engineer and will be working in teams on delivering projects and providing guidance to all team members at each stage of the design cycle.

Job Description

This role will be supporting Quality Design Assurance for the Infusion Pump platforms. The QE is involved in new product development and product maintenance through the application of Quality engineering skills.  

Plays an active role in the processes to ensure products meet quality standards consistent with both Corporate and division policies, while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements. Represents the Quality Function on Project Teams for both new product development and existing products.

Be the Quality Engineer

Primary Responsibilities

• Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical, Marketing, Systems Engineering, Software Engineering) for design change projects and develop close relationship with other quality functions (plant quality engineering, Supplier quality assurance…) as needed for the project .
• Responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. Adaptively apply working knowledge of quality engineering concepts within the product lifecycle.
• Write project quality plan
• Work on risk management activities within the project.
• Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements. Review and approve test protocol and reports. Review and approve related execution deviations.
• Assist / conduct Failure investigations and problem-solving sessions
• Review and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports.
• Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.
• Ensure process validation activities are completed appropriately and make the link with product design whenever needed.
• Conduct quality functional reviews and DHF compliance reviews.
• Ensure compliance across projects for design control, risk management and change control processes. Support Quality culture within R&D organization while providing training on applicable requirements / standards.

Scope of Responsibility

• Role assigned to MMS Infusion Platforms “Alaris+” and “GAI”
• Quality Engineer role based at Research Center Ireland, Limerick
• QE Role assignments includes R&D projects for New Product Introduction and Product maintenance (mechanical, electrical, software design….)
• QE role interacts with key functions across BD Worldwide organization (R&D, Operations, Reg Affairs, Medical Affairs) and external projects partners (key suppliers, contract labs, CMOs).

Position Specific Overview

• Reliability: Understand basic Reliability Engineering practices. Includes familiarity with: Reliability Growth Testing (RDT), Reliability Demonstration Testing (RDT), Life Test, HALT, HASS, Idealized Growth Curve, etc.
• Software: Understand the software development (SW) and testing life cycle as defined by ISO 62304.Experience supporting SW-related R&D design change efforts through development and/or testing. Understanding of SW issues tracking, automation, issues tracking, risk assessment and bug containment.
• Compliance: Ability to support R&D efforts specifically aimed at compliance with domestic or international (e.g. MDR, IEC 60601, 3rd Edition, ISO 13485) requirements. Experience supporting or navigating such projects. Interacting with governing bodies and test houses.
• Good understanding of technical aspects: injection molding, extrusion, polymer science, electrical engineering, mechanical engineering, chemical testing

Be Qualified:

• Bachelor’s Degree in Engineering required, electrical or mechanical preferred
• Knowledge in design assurance including design controls and risk management
• Knowledge of Capital Equipment validation
• General understanding of Statistical methods for quality assurance
• Ability to act as Change Agent and effectively manage change
• Experience working with cross-functional teams and remote teams, promote work in multidisciplinary teams
• Demonstrate strong and clear accountability for successful and timely completion of tasks

• Influence: Intuitively and quickly assess people and situations and act accordingly. Demonstrate persuasion and timing skills. Remain open to be persuaded when appropriate.

The BD Difference

BD, founded in 1897, is a global medical technology company with over 40,000 associates in over 100 countries. We create specialized devices, solutions and systems to address many of the world’s most pressing healthcare needs. We operate under a single purpose: “to advance the world of health”.

We have been a strong employer presence in Ireland for over 50 years. Join us and be our newest team member making the difference!

Primary Work Location

IRL Limerick - Castletroy

Additional Locations

Work Shift