Senior Design Assurance Engineer

An innovative medical technology company based in Galway, is seeking an experienced Senior / Principal Design Assurance Engineer to join their growing Quality and Regulatory Affairs team.

This is an exciting opportunity to play a key role in supporting the transition from product development to commercialisation within a fast-scaling organisation developing breakthrough technologies that improve the patient experience of cancer treatment.

The successful candidate will provide design assurance leadership and support across product development, verification and validation and design transfer activities, ensuring compliance, efficiency and scalability as the company grows.

You will be a proactive and innovative engineer who enjoys creative problem-solving and thrives in a collaborative, fast-moving environment. You will bring a strong sense of ownership, attention to detail and a passion for delivering products that make a real-world impact on patient lives.

RESPONSIBILITIES:

• Support and lead Design Verification and Validation activities, including the development of testing methods.

• Drive corrective and preventive actions to improve design and testing processes.

• Lead or support the Design Controls and Design Review processes.

• Contribute to the preparation of technical documentation for regulatory submissions.

• Develop and maintain test methods, work instructions and validation protocols.

• Support Human Factors and Usability Studies.

• Guide the transition of design activities into manufacturing, including FMEA handover and specification management.

• Collaborate with external design, manufacturing and supply partners.

• Mentor, coach, and train other team members.

REQUIREMENTS:

• Degree in Engineering, Science or a technical discipline (ASQ CQE accepted).

• Minimum 6 years’ experience in a Design Assurance or related engineering role.

• Experience within a medical device or regulated environment (ISO 13485 or equivalent).

• Proven track record in design controls, FMEA (Design & Process) and root cause investigations.

• Skilled in the use of statistical tools and proficient with Microsoft Office (Excel, Word).

• Strong communication and interpersonal skills, comfortable liaising with cross-functional teams and external partners.

• Highly organised, self-driven and able to prioritise effectively in a fast-paced setting.

ADVANTAGEOUS:

• Experience with process or test equipment validation.

• Prior exposure to start-up or SME environments.

• Knowledge of Design for Manufacturability (DFM) principles.

• Experience validating test methods, equipment or software.

• Background in sterile devices or electro-mechanical / software-containing medical devices.

BENEFITS

• Hybrid working model with flexibility.
• 24 days annual leave.
• Pension.
• Health Insurance.
• DIS benefit.
• Income protection.

• Opportunities for professional development and career progression.

• Collaborative, supportive culture focused on innovation and patient impact.