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

Senior Product Owner – Pharmacy Automation Software (Hybrid Durham, NC)

Senior Product Owner – Pharmacy Automation

📍 Location: Durham, North Carolina, USA
🏢 Work Model: Onsite 4 days per week / 1 day remote
💼 Employment Type: Full-Time
💰 Salary Range: $110,000 – $125,000
✈️ Travel: Up to 20% (domestic & international)

About the Opportunity

This is a high-impact Senior Product Owner role within a fast-growing Pharmacy Automation R&D organization at the forefront of healthcare technology. You’ll play a critical role in shaping software products that directly address some of the industry’s biggest challenges—clinician shortages, operational efficiency, and patient safety.

You’ll act as a subject-matter expert and strategic driver, translating customer and business needs into scalable, high-quality software solutions that deliver real-world value.

Your Mission

As a Senior Product Owner, your top priorities will be to:

1. Champion product strategy through the elicitation, refinement, and ownership of software product requirements

2. Partner with Software Delivery Leads to translate requirements into features and user stories

3. Deliver customer-delighting solutions that drive measurable business outcomes

Key Responsibilities

• Own and manage the software product backlog, including features, user stories, and defects

• Prioritize scope in collaboration with cross-functional teams while balancing risk, schedule, and resources

• Partner closely with Product Managers, Engineering, QA, and Delivery Leads to ensure value-driven execution

• Lead requirements engineering across the full SDLC (functional & non-functional)

• Support Agile ceremonies including sprint planning, estimations, reviews, and incremental delivery

• Drive product quality through continuous collaboration with engineering and QA teams

• Lead system design reviews and contribute to architectural discussions

• Ensure testability of requirements and support verification, validation, and UAT planning & execution

• Support beta launches, success criteria definition, and outcome documentation

• Act as an escalation point for production issues and provide third-line support

• Execute work within formal design controls, PLM, configuration management, and phase review processes

• Contribute to intellectual property generation and share domain expertise across teams

• Stay current with Agile best practices, industry trends, and competitive landscapes

Skills & Experience

• Strong expertise in Agile / Lean software development environments

• Hands-on experience with product and delivery tools such as Aha!, Jira, Azure DevOps

• Excellent communication, facilitation, and stakeholder leadership skills

• Strong analytical thinking and problem-solving capability

• High attention to detail with the ability to operate independently in complex environments

• Domain experience in Pharmacy, Healthcare, or Medical Technology

Qualifications

• Bachelor’s Degree or Pharmacy Technician Certification (CPhT) required

• 5+ years of relevant product ownership or related experience

Ideal Candidate Profile

• Local to the Durham, NC area

• Comfortable working on-site 4 days per week

• Strong background in healthcare or pharmacy-related software products

• Confident working cross-functionally in a regulated, fast-paced environment

Why Join

• Work on mission-critical healthcare technology with real patient impact

• Collaborate with high-performing global R&D teams

• Clear ownership, visibility, and influence over product outcomes

• Strong culture of accountability, learning, and continuous improvement

• Competitive salary, full benefits, and long-term career growth

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.

Senior Supply Chain Manager | Medical Devices | $150K–$160K | Sumter, SC

Job Title: Senior Supply Chain Manager
Location: Sumter, South Carolina (Onsite – Manufacturing Facility)
Industry: Medical Technology / Medical Devices
Employment Type: Full-Time
Seniority Level: Mid-Senior
Travel: Up to 25%
Visa Sponsorship: Not Available
Security Clearance: Not Required
Relocation Assistance: Possible for the right candidate
Compensation: $150,000–$160,000 base salary + full benefits
Bonus Eligible: No
Interview Travel Reimbursed: Yes

Overview:

This role is a strategic and hands-on leadership opportunity within a leading global medical technology manufacturer. The Senior Supply Chain Manager will lead the end-to-end supply chain operations for a high-volume manufacturing plant, overseeing planning, purchasing, sterilization, product flow, shipping, and master data governance. This individual will play a critical role in ensuring supply continuity, operational efficiency, inventory optimization, and cross-functional collaboration with corporate, regional, and site-based stakeholders.

Key Responsibilities:

Purchasing & Supplier Management

• Lead procurement of raw materials, components, MRO supplies, and capital equipment.

• Direct issuance of purchase orders and lead resolution of non-conforming materials with supplier quality teams.

• Collaborate with One Company Procurement (OCP) for corporate sourcing compliance and improvements.

Planning & Scheduling

• Align with global supply chain teams to balance plant efficiency with customer demand.

• Evaluate master production schedules and global demand for molded components.

• Drive production plan adjustments and support mitigation strategies for material shortages.

Master Data Management

• Oversee materials control documentation, ISO/QSR/SOX compliance, and ERP data governance.

• Lead process improvement initiatives in SAP and Apriso systems.

Sterilization Operations

• Oversee the operation and optimization of the on-site Gamma sterilizer – the plant’s bottleneck process.

• Liaise with microbiology, corporate sterilization, and assurance teams for SOP alignment and continuous improvement.

Shipping & Logistics

• Ensure talent and processes are in place to support outbound product flow to distribution centers and partner plants.

Leadership of Supply Chain Teams

• Directly manage 3 supply chain managers overseeing inbound, outbound, and planning functions.

• Represent the plant in divisional Integrated Reconciliation Meetings and strategic planning forums.

• Lead strategic initiatives including manufacturing transfers, make vs. buy analysis, and business continuity planning.

Reporting & Strategic Collaboration

• Prepare and analyze capacity reports, forecast alignment, and budget planning documents.

• Coordinate with finance, CI leadership, and marketing to ensure aligned business performance.

• Coach and develop a team of exempt supply chain professionals in line with corporate strategies.

Minimum Qualifications:

• Bachelor’s Degree in Business, Engineering, Supply Chain or a related field

• 10+ years of experience in supply chain management within a manufacturing environment

• Strong background in planning, procurement, supplier performance management, and logistics

• Proficiency in SAP and Apriso systems

• Demonstrated success in leading teams and managing cross-functional projects

Preferred Qualifications:

• 15+ years of total experience in manufacturing or supply chain operations

• Prior experience managing supply chain disruptions (e.g., raw material delays, port congestion)

• Background in strategic supplier negotiations, cost reduction, and demand forecasting

• Familiarity with ISO, QSR, and SOX compliance requirements

• Continuous Improvement (CI) and transformation experience, including digitalization

Work Environment:

• This is an on-site leadership role based in a non-smoking, regulated manufacturing environment.

• Steel toe, non-slip footwear is required in production areas.

• Jewelry, false eyelashes, press-on nails, and visible dermals are prohibited in production zones for safety and compliance.

Why Join?

• Be part of a high-performing, collaborative team that supports career growth and development

• Play a key role in ensuring medical products reach global customers safely and efficiently

• Join a company with a strong reputation for ethical operations, innovation, and global impact

• Contribute to critical healthcare solutions and operational excellence at a global scale

Field Service Engineer – Medical Equipment | Frankfurt & Surrounding Areas

Field Service Engineer – Frankfurt & Surrounding Areas (Remote with Travel)

Industry: Medical Equipment / Devices
Job Category: Technical Sales & Support

About the Role

We are seeking a Field Service Engineer to provide installation, maintenance, and repair services for flow cytometers in Frankfurt, Marburg, Heidelberg, and surrounding areas. This role requires a strong technical background, customer-focused approach, and the ability to work independently while collaborating with sales teams.

📍 Location: Fully remote within the assigned region
🕒 Employment Type: Full-time or part-time (flexible arrangement)

Key Responsibilities

🔧 Install, maintain, and repair flow cytometers following technical documentation
🔍 Diagnose and resolve technical issues on-site
📊 Work with the sales team to inform customers about technical service offerings (e.g., service contracts)
⭐ Ensure high customer satisfaction based on feedback and performance metrics
📂 Maintain accurate service records in the ERP system
🌍 Participate in technical training programs, including international training sessions

Your Profile

✅ Education & Experience:

• Technical degree or equivalent qualification in medical technology, electronics, or a related field

• 2+ years of experience in field service or technical support, preferably with medical devices or high-tech equipment

✅ Technical Skills:

• Strong knowledge of computers, networking, and electronics

• Ability to self-manage, prioritize tasks, and work efficiently

• Analytical thinking with strong problem-solving skills

• Fluent in German, with good English proficiency

✅ Other Requirements:

• Valid EU driver’s license

• Willingness to travel frequently within the assigned region and occasionally within Central Europe

What We Offer

💰 Salary: €60,000 – €65,000 per year
🎁 Benefits:

• 13th-month salary (paid in June & November)

• Stock purchase plan (after 6 months)

• Accident & international health insurance

• Childcare allowance

• Company car allowance (if applicable)

• Training & career development opportunities

• Special leave (e.g., wedding)

• Christmas & New Year’s Eve company holidays