Senior Medical Device Design Assurance Engineer

Saluda Medical; Sydney; On-site; AUD 120,000 - 180,000; Full time

Job summary

Saluda Medical is seeking a Senior Design Assurance Engineer to join its Quality Management team. You will provide quality engineering support across new product development, sustaining, and post-market activities to ensure design controls and production processes meet regulatory requirements.

You will lead risk management, verification/validation documentation, and design change control, collaborating with cross-functional teams to deliver compliant, reliable medical devices.

Qualifications

• Bachelor’s degree or higher in Biomedical, Mechanical, Electrical, Software or related technical field.
• Experience with medical device design assurance and design controls.
• Familiarity with ISO 13485, ISO 14971, and 21 CFR 820.
• Strong analytical and problem-solving abilities.
• Excellent verbal and written communication; able to present to stakeholders.
• Ability to work independently and in cross-functional teams.

Responsibilities

• Identify and implement design controls with cross-functional teams.
• Ensure compliance of design and changes with internal and regulatory requirements.
• Mentor teams on design control and risk management deliverables.
• Conduct risk analyses using FMEA and related tools.
• Stay updated on regulatory requirements for product design and transfer.
• Support quality disciplines and decisions within the team.
• Liaise with internal and external departments to build partnerships.
• Review design verification test plans, protocols, and reports.
• Develop test method validation requirements.
• Apply statistical methods to assess product reliability and process capability.
• Plan and prioritize daily work to meet schedule.

Skills

Cross-functional teamwork

Risk management

FMEA

Statistical analysis

Design verification

DHF documentation

Regulatory compliance

Analytical skills

Communication

Independent work

Education

Bachelor’s degree in a technical field

Job description

Saluda Medical is seeking a Senior Design Assurance Engineer to join its Quality Management team. You will provide quality engineering support across new product development, sustaining, and post-market activities to ensure design controls and production processes meet regulatory requirements.

You will lead risk management, verification/validation documentation, and design change control, collaborating with cross-functional teams to deliver compliant, reliable medical devices.