Principal Systems & Regulatory Software Engineer (Medical Devices)

X4 Technology

Kent

1 month ago

Applications closed

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Senior Systems & Regulatory Software Engineer

Medical Devices | High Salary or High-Rate Contract | Kent | Hybrid

A cutting-edge medical technology company based in Kent is seeking an experienced Systems / Regulatory Software Engineer to play a pivotal role in the development of next-generation medical devices.

This is a rare opportunity to join a business where engineering rigour, regulatory excellence, and modern software practices genuinely coexist. The role can be structured either as a highly competitive permanent position or a well-remunerated contract engagement, depending on preference.

The Opportunity

You will work at the heart of a multidisciplinary engineering team, helping to define, govern, and deliver high-assurance medical software across the full product lifecycle.

This role suits someone who enjoys systems thinking, understands how to balance regulatory compliance with delivery pace, and can act as a technical authority across IEC 62304, ISO 13485, and risk-driven development.

You’ll be influential in shaping process, architecture, and engineering culture, while remaining close to the technical detail.

Key Responsibilities

Own and evolve software lifecycle processes aligned to IEC 62304 and ISO 13485
Lead system-level requirements, architecture, and risk management activities
Ensure compliance with ISO 14971 (beneficial standard) risk management and medical device regulations
Act as a technical interface between software, systems, QA/RA, and hardware teams
Support audits, technical files, and regulatory submissions
Guide and mentor engineers on high-assurance development practices
Drive continuous improvement across SDLC, DevOps, and validation activities

Technical Environment

Languages: C / C++
Platforms: Embedded Linux, Yocto
Tooling: Azure DevOps (CI/CD, requirements, test management)
Operating Context: Safety-critical, regulated medical software

Background & Experience

Strong experience in medical device software or similarly regulated environments
Proven application of IEC 62304 and ISO 13485 in real-world product development
Solid understanding of systems engineering, requirements, and traceability
Comfortable working across embedded software, DevOps, and quality processes
Able to influence both technical delivery and regulatory strategy
Confident communicator with engineers, quality, and senior stakeholders

Why This Role?

High-impact position within a genuinely innovative medical technology company
Choice of high-salary permanent role or premium contract engagement
Work on life-critical products with real-world clinical impact
Hybrid working with a Kent-based engineering hub
Engineering-led culture that values experience, pragmatism, and quality

If you are a systems-minded engineer with deep regulatory expertise and want to work at the forefront of medical technology—without bureaucracy for bureaucracy’s sake—we’d welcome a confidential conversation.

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