Job Description
At BD, we are committed to advancing the world of health. Every day, our teams develop innovative medical technologies that help improve patient outcomes and transform healthcare worldwide.
We are now looking for a Software Quality Engineer II to join our Limerick team. This role is key in ensuring our software-enabled medical devices meet high standards of quality, safety, performance, and legal compliance.
In this role, you will partner closely with R&D, software engineering, and multi-functional project teams to drive quality throughout the entire software creation and delivery process. You'll support both new product creation and ongoing maintenance activities, ensuring products meet customer expectations as well as global regulatory requirements.
In the role of Software Quality Engineer II, you will support Software Quality Build Assurance activities for BD's UCC product portfolio. You will work across multiple projects simultaneously, helping to ensure products are developed and maintained following build control requirements, regulatory standards for quality systems, and industry guidelines.
You will serve as the Quality representative on project teams, delivering proficiency in software reliability, risk management, validation, and regulatory compliance while collaborating closely with engineering and product development teams.
Responsibilities Include:
•Represent Quality on product creation and sustaining project teams involving multiple functions.
•Ensure Design Control principles are optimally applied to new product development and product/process changes.
•Lead quality initiatives across the entire product lifecycle, from concept through commercialization and maintenance.
•Develop, review, and approve risk management documentation, including Risk Management Reports, Hazard Analyses, Risk-Benefit Analyses, and FMEAs.
•Support and lead failure investigations, root cause analyses, CAPAs, and continuous improvement projects.
•Review and approve build specifications, verification and validation procedures and reports, software validation documentation, and test method validations.
•Drive quality planning activities for projects dedicated to product innovation.
•Ensure compliance with build regulation, risk management, and change control processes.
•Promote a strong quality culture within the R&D organization through mentoring, training, and relevant mentorship requirements and guidelines.
Skills and Experience Required:
•Bachelor's degree in Science, Technology, Engineering, Mathematics, or a related subject area.
•Experience in software quality engineering within a regulated environment.
•Strong understanding of Software Development Lifecycle (SDLC) processes and software validation activities.
•Experience developing, reviewing, and delivering test plans, test cases, and validation protocols.
•Understanding of quality systems and regulatory requirements related to medical technology.
•Excellent verbal, written, and presentation skills.
•Strong analytical and problem-solving abilities.
•Ability to influence and collaborate optimally across multidisciplinary teams.
•A proactive approach with a passion for continuous improvement and product quality.
•Ability to communicate effectively with audiences ranging from technical contributors to senior leadership.
Preferred Experience
•Knowledge of medical device standards and regulations including: ISO 13485, ISO 14971, FDA Quality System Regulations (21 CFR Part 820), IEC 62304 Medical Device Software Lifecycle Processes, IEC 62366 Usability Engineering.
•Experience with Design Verification, Design Validation, Software Validation, and Test Method Validation.
•Experience supporting risk management activities and design control processes.
•Experience participating in audits, CAPA activities, and failure investigations.
•Strong project management and prioritization skills with the ability to manage multiple assignments simultaneously.
Please note: The position is based at our Limerick site where we work a 4 days per week hybrid model.
Why Join BD?
At BD, you'll have the opportunity to work on meaningful technologies that impact millions of lives worldwide. You'll join a collaborative environment where innovation, quality, and professional development are encouraged and supported.
Primary Work Location
IRL Limerick - Castletroy
Salary Range Information
€44,800.00 - €68,350.00 EUR Annual
