Senior Quality Design Assurance Engineer

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 a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed-loop neuromodulation platform. The company’s proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real-time neurophysiological feedback.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient's lives.

** Please Note: This role is 6 Month Fixed Term position **

The Senior Quality Design Assurance Engineer is part of our Quality Management team, working alongside engineers in new product development, sustaining engineering and post-market activities. This role is a 6 month fixed term position which will provide quality engineering support to cross-functional teams to ensure the application and compliance to design controls and subsequent production and process controls are adequate. Specifically, this role will provide quality engineering support to the development of product technical documentation including requirements, product verification and validation, risk management, and design change control for a 6 month term.

Accountabilities and Associated Responsibilities:

• Work on a cross-functional team to identify and implement effective design controls and support product development from concept through commercialization.
• Understanding of Design Assurance requirements to support product design and design changes through cross-functional team collaboration, to ensure activities comply to all internal and regulatory requirements.
• Mentor cross functional teams through product development process; specifically, with respect to design control and risk management deliverables.
• Completes risk analysis studies of design and processes using FMEA and other Risk Management tools.
• Maintain up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities.
• Represent Quality by supporting quality disciplines, decisions, and practices.
• Liaise with departments, both internally and externally to build strong collaborative partnership.
• Support changes to DHF documentation.
• Review and approve design verification test plans, protocols and reports.
• Develop test method validation requirements.

• Utilize statistical analysis techniques to determine required level of product reliability and evaluate process capabilities.

• Provide Quality input to sustaining commercial product, process improvements and change control.
• Support cross functional team to develop protocols to ensure that design/process changes are adequately evaluated/tested with respect to standard requirements
• Plan, organize and prioritize own daily work routine to meet established schedule.

Essential Requirements:

• Bachelor’s degree or higher in a technical field (Biomedical, Mechanical, Electrical, Software Engineering or other technical field)
• Comfortable working independently and as part of a cross-functional team
• Flexible and positive attitude, team-oriented
• Good communication skills (verbal and written), comfortable speaking and presenting to others
• Ability to manage multiple priorities and work with ambiguity
• Must be able to work independently under limited supervision
• Strong analytical skills

• Design Assurance work experience in the medical device industry

• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820

Desirable Requirements:

• Design assurance experience in medical device firmware
• Design assurance experience in medical device software
• Medical device cybersecurity experience