Principal Software Quality Engineer

Metric Bio; California; Sur place; USD 150 000 - 230 000; Plein temps

Résumé du poste

Metric Bio is seeking a Principal Software Quality Engineer to provide technical ownership of software quality and regulatory compliance for next-generation minimally invasive medical devices.

This newly created role guides design controls, verification and validation, risk management and software lifecycle processes, while driving cybersecurity readiness and regulatory submissions. You will partner with R&D, Regulatory and Quality teams and mentor engineers across the organization.

Qualifications

• 10+ years in Software Quality Engineering, testing or development in regulated medical devices.
• Expertise in IEC 62304, FDA software requirements, and medical device cybersecurity.
• Experience with Class II/III medical devices, energy-based or cardiovascular tech.
• Knowledge of software V&V, design controls, ISO 14971, CAPA and regulatory documentation.
• Independent, collaborative technical expert guiding software teams and influencing cross-functional decisions.

Responsabilités

• Serve as the technical authority for software quality, guiding 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 with R&D, Regulatory and Quality teams, mentoring engineers and strengthening internal software quality capabilities.

Connaissances

Software quality

Regulatory compliance

IEC 62304

FDA requirements

Software V&V

Design controls

Cybersecurity

Leadership

Cross-functional

Description du poste

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.

The Opportunity

• 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.

What I'm Looking For

• 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.

Why Consider This Opportunity?

• 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.