Senior Design Assurance

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

Senior Design Assurance Engineer

Location: Galway (Hybrid)

Employment Type: Permanent, Full-time

Are you looking to transition your design assurance expertise into a high-growth environment where your technical contributions directly influence patient outcomes? We are currently seeking a Senior Design Assurance Engineer to join a multi-award-winning medical device SME based in Galway. This is a pivotal opportunity for a quality professional who thrives in a dynamic setting and wishes to play a key role in the commercialisation of innovative at-home administration technologies.

Role Overview

As a Senior Design Assurance Engineer, you will serve as a technical lead for quality activities across an expanding product portfolio. You will ensure that all design controls, verification, and validation activities meet stringent regulatory standards while the company scales from development to commercial stages. This role offers the chance to influence the design of new products and processes from the ground up, ensuring scalability and compliance at every step.

Key Responsibilities

• Support and oversee Design Verification and Design Validation testing protocols.
• Lead or support CAPA investigations to enhance product designs and test methodologies.
• Manage Design Controls and participate in formal Design Reviews to ensure robust product development.
• Compile comprehensive technical documentation required for regulatory submissions.
• Facilitate Human Factors and Usability studies to ensure user-centric design.
• Provide technical guidance, coaching, and training to junior team members.
• Manage the transition from design to manufacturing, including the evolution of DFMEA to PFMEA and the creation of manufacturing specifications.
• Collaborate closely with external design and manufacturing partners and suppliers.

Essential Requirements

• A Level 8 degree in Engineering, Science, or a related STEM discipline, or an ASQ CQE certification.
• A minimum of 3 years of relevant engineering experience within the medical device sector.
• Demonstrated experience working within an ISO 13485 Quality Management System.
• Proficiency in Design Controls, Design Reviews, and Design Change processes.
• Strong expertise in Risk Management, specifically FMEA, DFMEA, and PFMEA.
• Proven ability in problem-solving and conducting root cause investigations.
• Competence in data analysis using tools such as Excel, Minitab, or other statistical software.
• Excellent technical writing skills for engineering documents and validation protocols.

Desirable Skills

• Familiarity with IEC 60601 (Electrical Safety) and IEC 62304 (Software Lifecycle).
• Understanding of ISO 10993 (Biocompatibility).
• Experience engaging with regulatory agencies or notified bodies.
• Prior experience within a start-up or SME environment.
• Background in validating test methods, equipment, or software.

What the Opportunity Offers

You will join a forward-thinking organisation that values technical excellence and professional growth. The company offers a flexible hybrid working model and a compensation package comparable to major multinational medical device firms in the region.

Benefits include health insurance, a pension scheme, a generous vacation policy, and a full suite of professional hardware (laptop, headphones, camera).

Equal Opportunity Statement

Our client is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees regardless of background.