Senior Software Quality Engineer – Medical Devices | Limerick, IRE

Senior Software Quality Engineer

📍 Location: Limerick, Ireland
🏢 Work Model: Hybrid – Minimum 4 days onsite
💼 Employment Type: Full-Time
💰 Salary: €60,000 – €70,000
✈️ Travel: Occasional
🎓 Education: Bachelor’s Degree in Engineering or related technical field

Role Overview

A leading global medical technology organization is seeking a Senior Software Quality Engineer to support research and development programs focused on innovative medical technologies.

This role will be responsible for establishing and maintaining software quality processes, regulatory compliance, and design control systems to ensure the successful development and delivery of high-quality medical device software.

The position plays a key role in new product development, manufacturing transfer, and quality management system implementation, ensuring software systems meet both regulatory standards and customer expectations.

Key Responsibilities

Software Quality & Compliance

• Develop and maintain software quality strategies, processes, and procedures

• Ensure compliance with medical device regulatory standards including:

• FDA 21 CFR Part 820

• FDA 21 CFR Part 11

• ISO 13485

• ISO 14971

• IEC 62304

• EU MDR 2017/745

• Guide computer system validation (CSV) and electronic records compliance

Design & Development Quality

• Support software lifecycle activities including:

• Requirements management

• Software development planning

• Risk management

• Verification & validation (V&V)

• Facilitate design reviews and functional reviews

• Review and approve technical documentation including:

• Design documentation

• Verification and validation protocols

• Product drawings

Cross-Functional Collaboration

• Represent the Quality function within New Product Development teams

• Work closely with R&D, manufacturing, and engineering teams

• Support technology transfer initiatives between development and manufacturing environments

Continuous Improvement & Quality Systems

• Contribute to the development and implementation of quality management systems

• Support CAPA investigations and remediation activities

• Drive improvements in test coverage, software reliability, and system performance

Data Analysis & Problem Solving

• Apply statistical tools and quality methodologies to:

• Identify root causes

• Analyse product or process issues

• Implement corrective actions

Required Qualifications

• Bachelor’s degree in:

• Software Engineering

• Electrical Engineering

• Biomedical Engineering

• Mechanical Engineering

• Or a related technical discipline

• 6–7 years of professional experience in engineering or quality roles

• At least 4+ years of experience in software development lifecycle or software quality

• Strong understanding of medical device regulatory requirements

• Experience with:

• Software validation

• Design controls

• Risk management processes

• Strong analytical, problem-solving, and communication skills

Preferred Experience

• Experience in medical devices, healthcare technology, or regulated environments

• Familiarity with CAPA processes and audit remediation

• Knowledge of:

• Six Sigma methodologies

• Root cause analysis tools

• Statistical sampling techniques

• Experience working on cross-functional product development teams

Ideal Candidate

The ideal candidate is a software quality specialist within regulated industries who:

• Has strong experience in medical device software compliance

• Understands design controls and validation processes

• Can support new product development programs

• Works effectively with cross-functional engineering teams

• Applies structured problem-solving and quality methodologies

Why Join

• Opportunity to work on cutting-edge medical technologies

• Collaborative engineering and research environment

• Work with global teams driving healthcare innovation

• Strong culture of professional growth and technical excellence

Senior Quality Engineer – Design Assurance | Medical Devices | Limerick, Ireland

Senior Quality Engineer – Design Assurance

📍 Location: Limerick, Ireland
🏢 Work Model: Hybrid – Minimum 4 days onsite
💼 Employment Type: Full-Time
💰 Salary: €60,000 – €70,000
✈️ Travel: Occasional
🎓 Education: Bachelor’s Degree in Engineering or related discipline preferred

Role Overview

A global medical technology organization is seeking a Senior Quality Engineer – Design Assurance to support new product development and sustaining engineering projects.

In this role, you will act as the Quality representative on cross-functional project teams, ensuring that products meet global regulatory requirements and internal quality standards throughout the entire product lifecycle—from concept and development through product launch and ongoing support.

You will play a critical role in design controls, risk management, verification & validation, and regulatory compliance, helping deliver high-quality medical technologies that improve patient care.

Key Responsibilities

Design Assurance & Product Development

• Represent the Quality function on project core teams for new product development and design change projects

• Support product lifecycle activities from concept through launch and maintenance

• Ensure compliance with design control, risk management, and change control processes

Risk Management & Compliance

• Lead risk management activities throughout the product development lifecycle

• Support compliance with key standards such as:

• ISO 13485

• ISO 14971

• IEC 60601

• IEC 62304

• EU MDR

• Ensure regulatory requirements are integrated into development activities

Verification & Validation

• Support development and execution of verification and validation (V&V) strategies

• Review and approve test plans, protocols, and reports

• Evaluate statistical approaches and challenge testing methodologies where necessary

• Authorise and assess deviations during testing activities

Documentation & Quality Systems

• Contribute to the creation and maintenance of Design History File (DHF) documentation

• Support Quality Management System (QMS) activities including:

• CAPA investigations

• Field assessments

• Operational engineering evaluations

• Ensure accurate documentation and traceability across development programs

Issue Management & Continuous Improvement

• Support failure investigations and root cause analysis

• Manage software issue tracking in accordance with IEC 62304

• Promote a strong quality culture across project teams

Required Qualifications

• Bachelor’s degree in Engineering or related technical discipline
  (Equivalent experience considered)

• Minimum 5+ years of experience in Quality Engineering within a regulated environment

• Strong knowledge of:

• ISO 13485

• QSR / FDA quality requirements

• ISO 14971 risk management

• Statistical analysis techniques

• Experience with:

• Design assurance processes

• Design controls and change control

• Risk management methodologies

• Strong written and verbal communication skills

• Ability to manage multiple projects and priorities simultaneously

Preferred Experience

• Experience with EU Medical Device Regulation (MDR)

• Knowledge of:

• IEC 62304 (medical device software lifecycle)

• IEC 62366 (usability engineering)

• Experience supporting software-enabled medical devices

• Experience working with cross-functional product development teams

Ideal Candidate

The ideal candidate is a Quality Engineer experienced in regulated product development who:

• Has strong expertise in design assurance and risk management

• Understands the medical device regulatory landscape

• Can effectively influence cross-functional engineering teams

• Demonstrates strong attention to detail and analytical thinking

• Promotes a patient-first approach to quality and compliance

Staff Product Security Engineer | Medical Devices | Limerick, Ireland | Onsite

🔐 Staff Product Security Engineer

📍 Location: Limerick City, Munster, Ireland (Onsite – minimum 4 days per week)
🏢 Industry: Medical Devices / Healthcare Technology
🧠 Level: Mid–Senior
💼 Employment Type: Full-Time
✈️ Travel: Occasional
🛂 Visa Sponsorship: Not available
💶 Salary Range: €85,000 – €95,000
🎁 Benefits: Full benefits package

🚀 The Opportunity

An innovative global medical technology organisation is seeking a Staff Product Security Engineer to play a critical role in shaping and strengthening product security across next-generation healthcare solutions.

This is a highly visible position offering the opportunity to:

• Influence security strategy across product portfolios

• Embed secure-by-design principles across the full product lifecycle

• Lead security maturity improvements

• Work cross-functionally with R&D, Quality, Regulatory, and IT

• Protect products in an evolving threat landscape

If you're passionate about cybersecurity, product resilience, and impact-driven work in healthcare, this role offers both purpose and technical depth.

🎯 Key Responsibilities

• Lead and develop a high-performing Product Security function

• Define and guide product security strategy aligned with regulatory and enterprise cybersecurity objectives

• Embed secure-by-design practices, threat modelling, and proactive vulnerability management

• Partner with R&D, Quality, Regulatory, and IT teams to ensure security is integrated throughout the product lifecycle

• Conduct product security risk assessments and support remediation strategies

• Support product security documentation, including governance and compliance artefacts

• Review technical designs and source code; provide clear, actionable recommendations

• Support incident response and vulnerability management efforts

• Implement best practices for:

• Encryption & PKI

• Authentication & access control

• Audit logging

• Secure hardening

• Patch management

• Vulnerability monitoring

• Track and report security posture using meaningful metrics

• Ensure adherence to development policies and quality management systems

🧠 Required Experience & Qualifications

• Bachelor’s degree in Computer Science, Engineering, or related field (or equivalent experience)

• 5+ years experience in:

• Security architecture

• Secure software development

• Systems and architecture design

• Experience working in regulated environments with strong QMS adherence

• Proven experience leading or mentoring teams

• Strong understanding of:

• Encryption algorithms and PKI

• Embedded device security

• Networking and threat models

• Dynamic and static code analysis tools

• Excellent written and verbal communication skills

• Strong collaboration and stakeholder management abilities

🧩 Technical Skills Snapshot

Domain

Experience

Product Security

Secure-by-design, threat modelling, vulnerability management

Cryptography

Encryption, PKI

AppSec

Static/Dynamic analysis, secure SDLC

Embedded Security

Yes

Networking

Security controls, common threats

Documentation

SAP, SharePoint, DocuSign or similar

Regulated Environments

Medical / highly regulated industries

Tools

Microsoft Office, security tooling

🏢 Work Style & Culture

• Strong emphasis on onsite collaboration (minimum 4 days/week in office)

• Cross-functional, high-impact environment

• Focus on innovation, continuous improvement, and ownership

• Opportunity to influence product direction at a strategic level

📌 Candidate Snapshot

Attribute

Details

Role

Staff Product Security Engineer

Location

Limerick, Ireland

Experience

10–15 years ideal

Leadership

Yes (influence & team leadership expected)

Domain

Medical device security

Environment

Regulated, high-compliance

Work Model

Onsite-first

🌍 Why This Role Matters

Your work will directly contribute to:

• Protecting patient safety

• Strengthening cybersecurity in healthcare systems

• Ensuring regulatory compliance

• Driving security maturity across critical medical technologies

This is a career-defining role for someone who wants both technical depth and meaningful impact.