Senior Medical Device Systems Engineer & Regulatory Lead

On Q Recruitment Pty Ltd; Melbourne; In loco; AUD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

On Q Recruitment Pty Ltd in Melbourne is seeking an experienced Systems Engineer to lead our medical technology product portfolio, ensuring robust engineering processes, regulatory compliance, and seamless product integration.

You will drive requirements management, verification and validation, risk management, and system architecture decisions, collaborating with software, electronics, mechanical, and regulatory teams, mentoring engineers, and guiding FDA submissions.

Competenze

• A degree in Systems Engineering or related field.
• Significant medical device product development experience and Design Controls knowledge.
• Strong knowledge of systems engineering principles, requirements management, verification and validation.
• Experience with ISO 14971 risk management.
• Experience leading multidisciplinary engineering projects and stakeholder management.
• Strong problem-solving and communication skills, with FDA regulatory understanding.

Mansioni

• Lead systems engineering across the full product lifecycle.
• Define and manage system requirements, architecture, interfaces and traceability.
• Drive verification and validation to meet regulatory needs.
• Support FDA submissions and related regulatory activities.
• Ensure compliance with IEC 62304, IEC 60601, ISO 14971 and ISO 13485.
• Lead risk management across the product lifecycle.
• Collaborate with Software, Electronics, Mechanical, Manufacturing, Quality and Regulatory teams.
• Provide technical leadership and mentoring across disciplines.
• Drive continuous improvement of systems engineering processes.
• Support strategic technology decisions for future platforms.
• Work with external development partners and suppliers.

Conoscenze

Systems engineering

Regulatory compliance

Requirements management

Risk management

Stakeholder management

Leadership

Formazione

Systems Engineering degree

Biomedical Engineering degree

Strumenti

IEC 62304 knowledge

IEC 60601 knowledge

ISO 14971 knowledge

Descrizione del lavoro

On Q Recruitment Pty Ltd in Melbourne is seeking an experienced Systems Engineer to lead our medical technology product portfolio, ensuring robust engineering processes, regulatory compliance, and seamless product integration.

You will drive requirements management, verification and validation, risk management, and system architecture decisions, collaborating with software, electronics, mechanical, and regulatory teams, mentoring engineers, and guiding FDA submissions.