Principal Design Assurance Engineer - Medical Devices

Health and Aged Care Professionals; Sydney; Sur place; AUD 190 000 - 210 000; Plein temps

Avantages offerts par ce poste

Principal level role

Strategic influence & autonomy

Mentor engineers

Résumé du poste

Health and Aged Care Professionals in Sydney seeks a Principal Design Assurance Engineer to lead design assurance across complex medical device programs. You’ll stay hands-on while delivering strategic influence and mentoring the team, tackling challenging problems from design controls to V&V across high-risk implantable products.

You will collaborate closely with Product Development to ensure robust design decisions and regulatory readiness, and you’ll respond to regulator queries with credible

Qualifications

• Extensive experience developing regulated medical devices.
• Deep capability across Design Assurance, Systems Engineering, V&V, Design Quality or Product Development.
• Strong understanding of design controls and ISO13485, ISO14971 and 21 CFR 820.
• Experience supporting regulatory submissions and regulator queries.
• Mentoring and developing technical capability in others.
• Experience with Class II/III, implantable, connected or software-driven devices is highly regarded.

Responsabilités

• Acting as a senior technical voice across complex medical device development programs.
• Challenging and guiding Engineering on critical design and product decisions.
• Applying design controls and ISO14971 risk management throughout development.
• Reviewing requirements, architecture, risk controls and V&V evidence.
• Contributing substantially to complex technical investigations alongside Product Development.
• Responding to regulator questions and supporting regulatory submissions.
• Mentoring engineers and strengthening Design Assurance capability across the team.

Description du poste

Health and Aged Care Professionals in Sydney seeks a Principal Design Assurance Engineer to lead design assurance across complex medical device programs. You’ll stay hands-on while delivering strategic influence and mentoring the team, tackling challenging problems from design controls to V&V across high-risk implantable products.

You will collaborate closely with Product Development to ensure robust design decisions and regulatory readiness, and you’ll respond to regulator queries with credible