Hybrid Senior Software Quality Engineer – Design Controls Specialist bei BlueBridge Technology

About BlueBridge Technologies
At BlueBridge Technologies, we’re building the future of digital healthcare. From precision oncology to next-generation diagnostics, from clinical-grade wearables to breakthrough diabetes management tools — our work has real impact. As a team, we’re deeply committed to engineering excellence, regulatory rigour, and improving patient outcomes through innovation. We’re growing fast and looking for exceptional people to join us on this mission.

The Opportunity
We are seeking a Senior Software Quality Engineer – Design Control Specialist to join our dynamic and highly collaborative team. This is a key leadership role where you will ensure our products meet global regulatory standards while enabling our development teams to deliver safe, innovative, and effective digital medical solutions.

This is more than a compliance role — you will contribute to product strategy, shape processes, and engage directly with clients, regulators, and investors. You will be working across projects in oncology, diagnostics, genetic testing, wearable health, and beyond.

Why This Role?

• Be part of breakthrough innovation in medical technologies
• Lead design quality for cutting-edge digital health products
• Influence technical architecture and strategic direction
• Engage with regulators, clients, and stakeholders at the highest level
• Join a company with a people-first, purpose-driven culture

Your Responsibilities

You will work closely with multi-disciplinary teams (software, clinical, human factors, and hardware) and take ownership of:

• Leading software quality assurance activities across the product development lifecycle for multiple client projects, and ensuring compliance with relevant standards and regulations (including IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 820, EU Medical Device Regulations)

• Acting as the Design Controls SME (21 CFR 820.30) for key projects including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
• Developing and maintaining Design History File (DHF) / Technical File documentation, including Product Development Plans, Software Development Plans, User Needs, Software Requirements, V&V plans, Risk Assessments, Reports, etc.
• Leading software risk management activities in compliance with ISO 14971

• Chairing technical and phase gate design reviews

• Engaging with regulators (e.g. FDA), customers, and stakeholders as the voice of design quality
• Supporting post-market surveillance and managing quality escalations
• Leading audits and inspections, CAPAs, and ensuring alignment with quality KPIs
• Driving test planning and execution across unit, integration, and system levels
• Identifying and implementing new technologies to improve quality and efficiency
• Contributing to internal R&D and technology innovation initiatives
• Contributing to privacy and cybersecurity management
• Providing internal and external training on software quality and compliance best practices
• Guiding clients in establishing or improving their software QMS documentation and regulatory strategy.

• Supporting in the maintenance of the organisation’s Quality Management System

What We’re Looking For

Your Expertise

• 5+ years’ experience in regulated medical devices or other regulated industry
• Bachelor's or Master’s degree in Software Engineering, Computer Science, Biomedical Engineering, Quality Assurance, or a related field

• Expertise in IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR 820, and EU MDR

• Strong working knowledge of design controls (21 CFR Part 820.30)
• Experience with SaMD and/or software components of embedded medical devices
• Deep understanding of SDLC models (Agile, V-model) within regulated environments
• Experience leading risk management and managing DHFs
• Prior hands-on software development experience highly desirable

• Knowledge of cybersecurity standards (e.g., FDA Pre-market Cybersecurity, ISO/IEC 27001) preferred

Your Approach

• Clear, confident communicator and strong report writer
• Highly organised and detail-oriented
• Collaborative mindset with the ability to influence cross-functional teams
• Passionate about quality and continuous improvement
• Ethical, proactive, and able to work independently
• Open to learning and contributing beyond your core remit

Additional Details

• Occasional travel may be required (<20%), including international client or audit visits
• Flexible hybrid working available
• This role is based in Ireland
• A valid work permit is essential
• Competitive reward package including healthcare and pension

Working at BlueBridge Technologies

We’re proud to be a people-first company. At BBT, you’ll find a respectful, inclusive, and forward-thinking culture where your work has real impact. We support each other to grow, challenge assumptions, and push the boundaries of what’s possible in digital health.

As an equal opportunity employer, we welcome applicants from all backgrounds. If you require reasonable accommodations as part of the recruitment process, please let us know.