Engineer/Senior Systems Engineer
ResMed
Engineer/Senior Systems Engineer
Job Description
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 #LI-APACJoining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.
Locations
- Singapore, Singapore
Skills Required
- regulated industryintermediate
- design controlsintermediate
- ISO 13485 / ISO 14971intermediate
Required Qualifications
- Degree in Engineering (Biomedical, Mechanical, Materials, Chemical or similar) (degree in engineering)
- Degree in Engineering (Biomedical, Mechanical, Materials, Chemical or similar) (degree in engineering)
- 3–5 years (Engineer) or 5–8 years (Senior) experience (experience, 5 years)
- 3–5 years (Engineer) or 5–8 years (Senior) experience (experience, 5 years)
- Experience in a regulated industry (medical devices, healthcare preferred) (experience)
- Experience in a regulated industry (medical devices, healthcare preferred) (experience)
- Knowledge of design controls, risk management, and product lifecycle processes (experience)
- Knowledge of design controls, risk management, and product lifecycle processes (experience)
- Familiarity with ISO 13485 / ISO 14971 and verification and validation activities (experience)
- Familiarity with ISO 13485 / ISO 14971 and verification and validation activities (experience)
- Strong problem-solving mindset and systems thinking (experience)
- Strong problem-solving mindset and systems thinking (experience)
Responsibilities
- Support the ongoing lifecycle of released products, ensuring compliance with safety, quality, and regulatory standards
- Support the ongoing lifecycle of released products, ensuring compliance with safety, quality, and regulatory standards
- Maintain system requirements, risk management files, and design documentation
- Maintain system requirements, risk management files, and design documentation
- Collaborate with cross-functional teams (Engineering, Quality, Regulatory, Manufacturing) to evaluate and implement product changes
- 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
- 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)
- 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
- Support verification & validation and ensure end-to-end traceability
- Participate in design reviews, audits, and continuous improvement initiatives
- Participate in design reviews, audits, and continuous improvement initiatives
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