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

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.

Staff Electrical Engineer | Medical Devices | Limerick, Ireland

⚡ Staff Electrical Engineer I

📍 Location: Limerick City, Munster, Ireland

💼 Employment Type: Full-Time

🏭 Industry: Medical Devices / Healthcare Technology

🧠 Function: Electrical Engineering

🛂 Visa Sponsorship: Not available

🕒 Work Model: On-site (minimum 4 days per week)

________________________________________

🌍 About the Role

We are seeking an experienced Staff Electrical Engineer to play a key role in the design, development, and evolution of advanced electro-mechanical and automation systems within a highly regulated medical technology environment.

This role sits at the heart of engineering innovation — contributing to system architecture, driving electrical design excellence, ensuring compliance with international standards, and collaborating across multidisciplinary teams to deliver safe, scalable, high-performance solutions.

You’ll take ownership of electrical architecture, documentation, component selection, and testing across complex systems, while also influencing engineering best practices and contributing to next-generation platform development.

________________________________________

🔧 Key Responsibilities

• Design and develop electro-mechanical systems, components, and assemblies

• Contribute to system architecture and technical design decisions

• Define and implement technical requirements

• Create and maintain project plans

• Produce electrical schematics, wiring harness designs, and Bills of Materials

• Select and specify electrical components and technologies

• Perform electrical calculations, simulations, and technical evaluations

• Collaborate with suppliers and contract manufacturers

• Produce and maintain high-quality technical documentation (GDP)

• Conduct sample inspections and execute test plans

• Support continuous improvement in engineering standards and practices

________________________________________

🧠 Required Experience & Background

Education & Experience

• Bachelor’s degree in Electrical Engineering or related discipline

• 10+ years of relevant industry experience

Core Technical Expertise

• Strong electrical systems design background

• Experience in system and reliability engineering

• Regulatory knowledge (e.g. Machinery Directive)

• EMC (Electromagnetic Compatibility) knowledge

• Risk assessment and safety analysis experience

• Familiarity with EN 60204-1 and IEC 61010-1 standards

Tools & Technologies

• SolidWorks (essential)

• SolidWorks Electrical or EPlan (highly desirable)

• MS Office (advanced proficiency)

• Jira and ERP systems (e.g., Sage) – advantageous

• MS Project (basic experience preferred)

Engineering Methods

• Design Reviews

• DFMEA

• Design for Six Sigma

• Structured documentation practices

• System modelling and abstraction techniques

________________________________________

🤝 Personal Attributes

You are:

• Analytical and structured in your thinking

• Self-motivated and detail-oriented

• Comfortable working cross-functionally (engineering, quality, procurement, manufacturing)

• A strong communicator and collaborator

• Naturally curious with a drive to understand root causes

• Comfortable operating in regulated environments

________________________________________

🌟 Nice to Have

• German language skills

• Stakeholder management experience

• Experience across multiple industries

• Strong experience with safety tools (Safexpert, Sistema)

________________________________________

💶 Compensation & Package

• Salary Range: €70,000 – €80,000

• Benefits: Full benefits package

• Bonus: Not eligible

• Relocation: Not available

• Travel: Occasional

________________________________________

📌 Quick Snapshot

Category Details

Title Staff Electrical Engineer

Location Limerick, Ireland

Experience 10–15 years

Education Bachelor’s Degree

Work Model Primarily On-site

Industry Medical Devices

Level Mid-Senior

Salary €70K–€80K