Principal Software Quality Engineer

I'm hiring a Principal Software Quality Engineer for an innovative, publicly traded medical device company developing next-generation technologies for minimally invasive procedures.

With an expanding product portfolio and continued investment in product development and commercialization, this is a newly created position offering the opportunity to take technical ownership of software quality and compliance, influence product development and establish best practices across a growing organisation.

• Serve as the technical authority for software quality, guiding development teams on FDA requirements, IEC 62304 and regulatory compliance.
• Lead software quality oversight across design controls, verification & validation, risk management and software lifecycle processes.
• Drive software cybersecurity compliance, supporting regulatory submissions, risk assessments and evolving FDA requirements.
• Partner closely with R&D, Regulatory and Quality teams, mentoring engineers and strengthening internal software quality capabilities.

• 10+ years of experience in Software Quality Engineering, software testing or software development, including significant experience within regulated medical devices.
• Strong expertise in IEC 62304, FDA software requirements and medical device cybersecurity.
• Experience with complex Class II/III medical devices, ideally energy-based systems or cardiovascular technologies.
• Proven knowledge of software V&V, design controls, ISO 14971, CAPA and regulatory documentation.
• An independent, collaborative technical expert capable of guiding software teams and influencing cross-functional decisions.

• Newly created, high-impact position with genuine technical ownership and autonomy.
• Opportunity to shape software quality practices across innovative medical technologies.
• Direct exposure to senior leadership, with potential for future leadership progression.
• Competitive compensation, annual bonus, equity and comprehensive benefits.