Senior Systems Engineer- Devices Systems
On-site · Sydney, New South Wales, Australia
Job Summary
Senior Systems Engineer to guide devices systems from concept through verification and submission. Translate user, clinical, business, and regulatory needs into system requirements and risk assessments; lead requirements management and ensure traceability; develop system architectures and interface definitions for compliant product integration; collaborate across software, algorithm, electronics, mechanical, verification, and clinical teams; drive system-level risk management, safety controls, and evidence-based verification/validation; mentor engineers and contribute to tools/process improvements; require a Bachelor's in an engineering discipline and 5+ years' experience in medical device or regulated environments.
Required Qualifications
- Bachelor’s degree in Mechanical, Electrical/Electronics, Software, Biomedical, or related Engineering discipline
- 5+ years of experience in systems, product development, or engineering roles, ideally within medical devices or other regulated industries
- Strong understanding of systems engineering practices, including requirements management, risk management, verification, validation, and traceability
- Experience working across multidisciplinary engineering teams throughout the product development lifecycle
- Strong analytical, problem-solving, communication, and technical documentation skills
- Familiarity with medical device development processes, regulatory requirements, and quality management systems
- Preferred: Experience with software-intensive or connected medical devices; familiarity with software and algorithm development, integration, and verification; experience with engineering development tools (JIRA, Jama, Confluence)
- Experience mentoring engineers or providing technical leadership within project teams
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