Principal Design Assurance Engineer – Technical Lead

Healthcare Professionals Group; Sydney; Presencial; AUD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Healthcare Professionals Group in Sydney is seeking a Principal Design Assurance Engineer to lead technical challenges across high-risk medical device programs. This role blends hands-on engineering with strategic influence, overseeing design controls, risk management and V&V across design, systems and quality domains.

You’ll mentor engineers, collaborate with Product Development, and play a key role when regulators come asking questions, ensuring robust technical decisions and evidence.

Formación

• Experience developing regulated medical devices.
• Expertise across design controls and risk management.
• Ability to respond to regulator queries.

Responsabilidades

• Act as a senior technical voice across complex medical device development programs.
• Guide engineering on critical design and product decisions.
• Apply design controls and ISO14971 risk management throughout development.
• Review requirements, architecture, risk controls and V&V evidence.
• Contribute to complex technical investigations with Product Development.
• Respond to regulator questions and support regulatory submissions.
• Mentor engineers and strengthen Design Assurance capability.

Conocimientos

Design Assurance

Systems Engineering

V&V

Regulatory Judgement

Mentoring

Risk Management

Regulatory Submissions

Medical Devices

Herramientas

ISO13485

ISO14971

21 CFR 820

Regulatory Submissions

Descripción del empleo

Healthcare Professionals Group in Sydney is seeking a Principal Design Assurance Engineer to lead technical challenges across high-risk medical device programs. This role blends hands-on engineering with strategic influence, overseeing design controls, risk management and V&V across design, systems and quality domains.

You’ll mentor engineers, collaborate with Product Development, and play a key role when regulators come asking questions, ensuring robust technical decisions and evidence.