Product Design Control - Limerick

The majority of companies today operate in changeable industries adapting to customer needs, promoting innovation, regulatory requirements and staying competitive. Due to these challenges, today’s products are continually changing, e.g., making them lighter, smaller, faster, smarter. This has increased the demand for product development professionals such as engineers (mechanical, reliability, human factors, software), product/project managers, quality, risk management, and regulatory compliance leaders. The aim of the Level 9 Masters in Product Design Control Management is to equip learners with the competence to learn the primary concepts of product design control and the necessary skills needed to be successful in product development in a regulated environment. Particular focus on intended use, user needs, design input, design verification, design validation and design transfer. Learners will have the knowledge and skills to manage and contribute to each design stage: development planning, identifying design inputs, developing design outputs, verifying that design outputs meet design inputs, validating the design output meets the user needs, reviewing and approving design changes. Participating in design reviews, writing and approving design verification/validation plans, protocols and reports, and finally transferring the design to production, maintaining the product while meeting quality and regulatory standards. While also understanding the importance and role of Risk Management through each stage of the design development process.



There will be a total of 14 hours per week. Ten hours of classes will take place on campus on Tuesday and Wednesday. Four hours will be delivered online on Monday.

Semester 1

Product Design Control

Credits: 10

The learner will understand the importance of achieving the user needs and the linkage between each stage of the Design Control process from Design Input, Design History File, Design and Development Planning, Product Risk Management, Human Factors and Usability Engineering, Design Review, Design Output, Design Validation/Verification, Design Change and Design Transfer.



Quality Management

Credits: 10

Draws from International Standards for Quality Management, teachings of the various quality Gurus, National and International Quality Awards, and self-assessment models. Learners will develop skills to become leaders and innovators in the application of Quality principles techniques and develop as quality management professionals in the service and manufacturing industry.



Project Management

Credits: 10

Will introduce formal project management methodologies and the project management environment. Learners’ skills and knowledge will be developed in the tools and techniques documented in the Project Management Body of Knowledge (PMBOK). The module also adopts theoretical and active learning, as the learner will be required to identify and complete an individual industry-based project.



Dissertation (Year-Long Module)

Credits: 30

Focuses on preparing a research proposal and applying the findings from the literature review to the design, testing and execution of an in-depth research study. Focusing on Interpretation, reporting of findings, and formulating justified conclusions that address the research’s original aims and objectives.



Semester 2

Process Design Standards and Regulatory Affairs

Credits: 10

Provide learners with a fundamental understanding of EU and international regulatory systems required during process design. The module will cover the role of regulatory affairs, classification, regulatory structure, and the impact of various regulated industry submission pathways such as medical devices, pharmaceuticals, biopharmaceuticals, and Food manufacturers.



Design Verification and Validation

Credits: 10

Evaluates design verification and validation approaches, models, development, implementation, testing and maintenance of a product. The importance and application of design verification and validation management, reporting and risk management in the product lifecycle will be defined and evaluated.



Product Risk Management

Credits: 10

Gives the learner the ability to estimate and evaluate associated risks, control the risk, verify the control’s effectiveness, and understand each element of risk management. Work within risk management teams in planning, managing, and developing design failure mode analysis, ensuring that safe and effective products are delivered to the customer.



Dissertation (Year-Long Module)

Credits: 30

Focuses on preparing a research proposal and applying the findings from the literature review to the design, testing and execution of an in-depth research study. Focusing on Interpretation, reporting of findings, and formulating justified conclusions that address the research’s original aims and objectives.

A minimum honours bachelor degree (Level 8) in any discipline.



Or



A minimum ordinary bachelor degree (Level 7) in any discipline with minimum two years relevant work-based experience and/or ability, evidenced by an RPL portfolio of prior experience and learning



Or



Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered. International students must evidence a proficiency in English language for example IELTS 6.0

1 year

Career Opportunities

This programme will enhance a learner’s career in manufacturing, R&D and regulated companies by developing increasing levels of competence, professionalism, critical thinking, problem-solving and decision-making necessary to work in the regulated industry. This equips graduates to work in regulatory affairs, quality or/and engineering and science environments. There are multiple roles a graduate from the programme can seek in areas such as: Product Design Control, Design Control, Product Risk Management, R&D Engineer, Design Assurance Engineer, Product Manager, Regulatory Engineer, Validation Engineer, Quality Engineers, Quality Control, Quality Management, Regulatory affairs Management, Project Engineer, Product Management and Process Engineer.



Further Study

Upon successful completion of this programme, graduates have the opportunity to complete Level 9/10 programmes here at TUS or elsewhere.