Senior QA & Design Assurance Engineer – Medical Devices (6-Month)

Saluda Medical; Sydney; On-site; AUD 110,000 - 150,000; Full time

Job summary

Saluda Medical is seeking a Senior Quality Design Assurance Engineer for a 6-month fixed-term position in Sydney. You will support cross-functional product development, ensure alignment with design controls, risk management, and regulatory requirements, and mentor teams across the development lifecycle.

You will review verification activities, develop test validation plans, and contribute to DHF updates while maintaining knowledge of ISO 13485, ISO 14971, and 21 CFR 820 requirements.

Qualifications

• Bachelor’s degree or higher in a technical field essential for Design Assurance.
• Experience in medical device quality systems and design controls.
• Strong communication and collaboration across cross-functional teams.

Responsibilities

• Identify and implement design controls to support product development from concept to commercialization.
• Support design changes ensuring compliance with internal and regulatory requirements.
• Mentor cross-functional teams on design control and risk management deliverables.
• Perform risk analyses using FMEA and other risk tools.
• Maintain knowledge of regulatory requirements for design, development, transfer and commercialization.
• Support quality disciplines and decisions across departments to build strong partnerships.
• Assist changes to DHF documentation and related records.
• Review and approve design verification test plans, protocols and reports.
• Develop validation requirements for tests and test methods.
• Use statistics to determine product reliability and process capability.
• Contribute quality input to sustaining products and process improvements.
• Help develop protocols to evaluate design/process changes.
• Plan and prioritize daily work to meet schedules.

Skills

Design assurance

Risk management

FMEA

ISO 13485

ISO 14971

21 CFR 820

Cross-functional teamwork

Regulatory compliance

Statistical analysis

Technical writing

Education

Bachelor’s degree in Biomedical, Mechanical, Electrical, or Software Engineering

Tools

FMEA

Regulatory standards

Test protocols

Job description

Saluda Medical is seeking a Senior Quality Design Assurance Engineer for a 6-month fixed-term position in Sydney. You will support cross-functional product development, ensure alignment with design controls, risk management, and regulatory requirements, and mentor teams across the development lifecycle.

You will review verification activities, develop test validation plans, and contribute to DHF updates while maintaining knowledge of ISO 13485, ISO 14971, and 21 CFR 820 requirements.