Design Assurance Engineer

Sterling Engineering Ltd - Ireland & Europe; Galway; On-site; EUR 60,000 - 85,000; Full time

Job summary

Sterling Engineering Ltd in Ireland seeks a Design Assurance Engineer to support quality activities across the medical device product lifecycle. You will ensure compliance with design controls, risk management, QMS procedures, and regulatory requirements.

The role involves collaborating with cross-functional teams, customers, and suppliers to drive NPD from concept to launch. The ideal candidate has 3+ years in medical device quality assurance or design quality engineering, with experience in

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• Experience with design controls, risk management, and quality documentation in medical devices.

Responsibilities

• Lead quality engineering activities across new product development programmes, ensuring design control compliance.
• Develop and maintain quality documentation throughout the product development lifecycle.
• Ensure adherence to QMS, regulatory requirements, and ISO 13485 across projects.
• Manage DHF, DMR, and other essential quality documentation.
• Support risk assessments, verification and validation activities, and quality plans for pilot production and scale-up.
• Collaborate with cross-functional teams to ensure timely quality deliverables.

Skills

Design controls

Risk management

Quality documentation

eQMS

Education

Bachelor's degree in Engineering

Job description

We are seeking a Design Assurance Engineer to join a growing medical device development environment, supporting quality activities throughout the product development lifecycle.

This is an excellent opportunity for an experienced Engineer to play a key role in ensuring that medical devices are developed in accordance with applicable regulatory requirements, industry standards and Quality Management System (QMS) procedures.

Working closely with cross-functional project teams, customers, and suppliers, you will support new product development (NPD) programmes from initial concept through to product launch and commercialisation.

The successful candidate will have experience in medical device quality assurance or design quality engineering, with a strong understanding of design controls, risk management, regulatory compliance, and quality documentation.

Key Responsibilities

Design Quality & New Product Development

• Lead quality engineering activities across new product development programmes, providing technical guidance and ensuring compliance with design control requirements.
• Develop and maintain quality documentation throughout the product development lifecycle.
• Ensure project teams adhere to the Quality Management System, applicable regulatory requirements, and relevant industry standards.
• Manage design control activities, including the preparation and maintenance of Design History Files (DHF), Device Master Records (DMR), and other essential quality documentation.
• Support the documentation of user needs, product requirements, risk assessments, and verification and validation activities.
• Develop quality plans to support pilot production, process scale-up, and successful product commercialisation.

Risk Management & Regulatory Compliance

• Conduct design risk assessments to evaluate product safety, performance, and suitability for intended use.
• Ensure risk management activities are effectively implemented throughout product development.
• Support compliance with applicable medical device regulations, FDA requirements, ISO 13485, and internal quality procedures.
• Lead and support product verification and validation activities, ensuring appropriate documentation and evidence are available to demonstrate compliance.

Quality Systems & Continuous Improvement

• Manage and support Corrective and Preventive Actions (CAPA), change control, change notifications, document control, and product release activities.
• Ensure compliance with established Quality Management System procedures.
• Support internal, customer, supplier, and regulatory audits, including the preparation of quality documentation and audit evidence.
• Identify and implement continuous improvement initiatives to enhance product quality, process efficiency, and regulatory compliance.
• Investigate and support the resolution of technical and quality issues, ensuring appropriate corrective actions are implemented.
• Develop and maintain effective working relationships with customers, suppliers, and external consultants.
• Communicate proactively with stakeholders to ensure timely information exchange and resolution of quality-related issues.
• Support supplier qualification activities and conduct supplier audits where required.
• Coordinate with external suppliers and consultants to ensure materials and services are delivered in line with project timelines.
• Collaborate with cross-functional teams to support project milestones and successful product development outcomes.

Manufacturing & Process Support

• Work closely with operations and manufacturing teams to develop robust manufacturing processes and clear work instructions.
• Support the introduction of new materials, equipment, processes, methodologies, and products.
• Contribute to quality planning for pilot production, process scale-up, and commercial manufacturing.

Requirements

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum of 3 years' experience in medical device design and development, quality assurance, or a related quality engineering role.
• Working knowledge of medical device regulations, FDA Quality System Regulation (QSR) requirements, and ISO 13485.
• Experience with design controls, risk management, and quality documentation within a medical device environment.
• Understanding of CAPA, change control, document control, and Quality Management System requirements.
• Experience supporting product verification and validation activities.
• Excellent written and verbal communication skills, with the ability to engage professionally with customers, suppliers, and internal stakeholders.
• Strong organisational skills, with the ability to manage multiple priorities and meet project deadlines.
• A proactive, analytical, and solutions-focused approach to problem-solving.
• Experience using an electronic Quality Management System (eQMS).
• Experience developing manufacturing processes and work instructions in collaboration with operations teams.
• Previous experience supporting or conducting supplier, customer, internal, or third-party audits.
• Lean or Six Sigma training or certification.
• Knowledge of probability, statistics, and risk-based decision-making.
• Experience working within cross-functional product development teams.
• Demonstrated ability to lead quality activities from early-stage product development through to product launch.