Senior Design Assurance Engineer — Hybrid MedTech Leader

Life Science Recruitment; Galway; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Pension scheme

Generous vacation policy

Professional hardware

Job summary

Life Science Recruitment is seeking a Senior Design Assurance Engineer in Galway to lead quality activities across an expanding product portfolio in a high-growth medical device SME.

You will ensure design controls, verification, validation, and DFMEA/PFMEA are compliant with ISO 13485, while collaborating with suppliers and internal teams to drive robust product development and regulatory submissions.

Qualifications

• A Level 8 degree in Engineering, Science, or related STEM discipline, or ASQ CQE.
• 3+ years in medical device quality engineering.
• Experience with ISO 13485 QMS and design controls.
• Proficiency in design verification/validation, design reviews, and change control.
• Strong root-cause analysis and problem-solving abilities.
• Data analysis using Excel or Minitab; excellent engineering documentation.

Responsibilities

• Lead and support Verification and Validation testing protocols.
• Manage CAPA investigations to improve designs and tests.
• Oversee Design Controls and participate in Design Reviews.
• Prepare technical documentation for regulatory submissions.
• Conduct Human Factors studies to support user-centred design.
• Provide coaching and training to junior team members.
• Transition from design to manufacturability with DFMEA/PFMEA evolution.
• Collaborate with external design/manufacturing partners and suppliers.

Skills

Design Controls

Design Reviews

Design Change

Risk Management

Problem solving

Data analysis

Technical writing

Education

Level 8 degree in Engineering/Science

Tools

Excel

Minitab

Job description

Life Science Recruitment is seeking a Senior Design Assurance Engineer in Galway to lead quality activities across an expanding product portfolio in a high-growth medical device SME.

You will ensure design controls, verification, validation, and DFMEA/PFMEA are compliant with ISO 13485, while collaborating with suppliers and internal teams to drive robust product development and regulatory submissions.