System Engineer / Senior System Engineer 

Location: Singapore or Sydney 

We’re looking for a Systems Engineer / Senior Systems Engineer to join our team and play a key role in supporting the lifecycle of innovative healthcare products used globally. 

If you enjoy solving complex problems, working cross-functionally, and making a real impact on product quality and patient safety—this could be the role for you. 

What you’ll do 

• Support the ongoing lifecycle of released products, ensuring compliance with safety, quality, and regulatory standards 

• Maintain system requirements, risk management files, and design documentation 

• Collaborate with cross-functional teams (Engineering, Quality, Regulatory, Manufacturing) to evaluate and implement product changes 

• Support investigation of field issues and customer feedback using structured root cause analysis 

• Contribute to post-market surveillance and risk management activities (e.g., Hazard analysis, safety risk assessments) 

• Support verification & validation and ensure end-to-end traceability 

• Participate in design reviews, audits, and continuous improvement initiatives 

For Senior Engineers: 

• Lead projects or workstreams independently 

• Mentor junior engineers and drive best practices 

What you bring 

• Degree in Engineering (Biomedical, Mechanical, Materials, Chemical or similar) 

• 3–5 years (Engineer) or 5–8 years (Senior) experience 

• Experience in a regulated industry (medical devices, healthcare preferred) 

• Knowledge of design controls, risk management, and product lifecycle processes 

• Familiarity with ISO 13485 / ISO 14971 and verification and validation activities 

• Strong problem-solving mindset and systems thinking 

Why join us? 

• Work on products that directly impact patient outcomes globally 

• Collaborate with a diverse, cross-functional international team 

• Opportunity to grow across Singapore or Sydney locations 

• Be part of a culture that values quality, innovation, and continuous improvement 

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