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Senior Design Assurance Engineer

Job description

Benefits
  • End-to-end ownership across the medical device lifecycle
  • High-visibility partnership with Product Development
  • Real influence over design assurance decisions
  • Exposure to complex, patient-impacting technology
 
 
About the Company
A fast-growing global MedTech developing advanced implantable devices.
 
Operating across Australia and the US, the organisation combines strong technical leadership with a collaborative, cross-functional structure and a reputation for innovation and high standards.
 
 
About the Opportunity
This Senior Design Assurance Engineer role sits within Quality and partners closely with Product Development. You’ll own design assurance across new product development and selected sustaining activities, ensuring design controls, risk management, and verification are practical, compliant, and effective.
 
You’ll collaborate alongside a confident, high-calibre team, playing a key role in decision-making, risk mitigation, and keeping projects moving in a fast-paced environment.
 
This role directly shapes product quality, regulatory outcomes, and how design assurance evolves as the organisation scales.
 
 
Duties
  • Own design assurance across development programs
  • Review and approve design documentation and reports
  • Lead risk management and challenge decisions
  • Partner closely with Product Development
  • Support verification, validation, and design changes
  • Provide quality input to sustaining activities
 
 
Skills & Experience
  • Engineering or technical degree
  • Medical device design assurance exposure
  • Design controls and risk management
  • Strong stakeholder engagement
 
 
Culture
Collaborative, fast-moving, and technically driven; ideal for someone who enjoys ownership, influence, and working shoulder-to-shoulder with strong teams.