Systems Engineer

Systems Engineer page is loaded## Systems Engineerlocations: Sydney, NSW, Australia: Singapore, Singaporetime type: Full timeposted on: Posted Todayjob requisition id: JR\_ Joining ResMed will provide you an opportunity to make a difference in someone’s life by offering better solutions for them to live a healthier life. Through this job, you can really say you’re contributing to the health of others. As an engineer you will participate as a team member within larger projects, but also lead your own initiatives and projects.ResMed practices a flexible working environment and achieves its success through diverse collaborative teams. You will have opportunities to develop a network of like-minded people and develop further in your engineering journey. We ask you to be your authentic self, to always speak your mind and to bring your best.We are in search of a passionate **Systems Engineer** to join our Product Development team at ResMed, where you will play a pivotal role in defining requirements and delivering innovative, patient-centered solutions. Together, we prioritize patient safety through meticulous and robust testing, while also championing the long-term sustainability of our products across their lifecycle.**Let's talk about the role*** **Support systems engineering activities for released products**, ensuring they continue to meet safety, performance, quality, and regulatory expectations across global markets.* **Maintain and update system requirements, design documentation, and risk files** as part of sustaining engineering, ensuring changes preserve design integrity and compliance.* **Collaborate across engineering disciplines** (Mechanical, Materials, Manufacturing, Quality, Regulatory, Supplier Quality, and Product Lifecycle Engineering) to evaluate and implement sustaining changes such as cost optimizations, supplier transitions, component updates, and compliance-driven modifications.* **Lead or support structured investigations** into field issues, customer complaints, and post-market trends—performing root-cause analysis and contributing to effective corrective and preventive actions.* **Participate in post-market risk management and surveillance activities**, updating risk assessments (FMEA, hazard analysis) based on field data, complaints, NCMR trends, and regulatory insights.* **Work closely with Verification & Validation teams** to ensure system requirements are adequately tested, verified, and validated for product updates and engineering changes.* **Maintain full traceability and design control compliance**, ensuring clear linkage between requirements, risks, specifications, and verification evidence.* **Support regulatory audits and inspections** by preparing compliant documentation, addressing findings, and ensuring systems engineering deliverables meet ISO, FDA, and global medical device requirements.* **Contribute to engineering change processes**, including updates to DHF/DMR, risk assessments, labeling, materials, and supplier information.* **Participate in cross-functional reviews**, providing system-level insights for technical issues, design modifications, and sustaining decisions.* **Collaborate with senior systems engineers** to enhance risk management rigor, strengthen documentation practices, and uphold quality system expectations.* **Contribute to continuous improvement initiatives**, helping strengthen system robustness, documentation quality, and lifecycle engineering processes.* Your work ensures Resmed’s products remain safe, reliable, compliant, and trusted by millions of users worldwide—long after product launch.**Let’s talk about Qualifications and Experience****Education:*** Bachelor’s degree in Engineering, preferably Mechanical, Biomedical, Chemical, or Materials Engineering/Science.* A postgraduate qualification in Biomedical Engineering is an advantage.**Experience:*** **3–5 years of engineering experience** with a systems-oriented mindset and strong analytical capabilities.* Experience working within **regulated industries**, ideally medical devices or consumer health.* Exposure to **post-market support, sustaining engineering, or lifecycle management** is valued.* Experience with **requirements management, risk assessment, design control, and compliance** processes in regulated environments.* Familiarity with **verification and validation activities**, test execution, and data-driven investigations.**Skills & Knowledge:*** Understanding of systems engineering principles, including requirements decomposition, interface definition, and traceability.* Ability to evaluate design alternatives and assess impacts of engineering changes.* Experience supporting **root-cause analysis**, structured problem solving, and technical investigations.* Familiarity with **ISO 13485**, **ISO 14971**, regulatory audits, and quality system processes.* Awareness of post-market surveillance processes and risk updates linked to field performance.**Attributes:*** Strong problem-solving mindset and ability to think in terms of systems and interactions.* Clear communicator who collaborates effectively with cross-functional teams.* Detail-oriented, quality-driven, and committed to patient safety.* Curious, proactive, and eager to grow under guidance from senior engineers.#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.#J-18808-Ljbffr