Senior Medical Device Systems Engineer – Full Lifecycle

Lead Group; Western Australia; Hybrid; AUD 140,000 - 150,000; Full time

Benefits offered by this job

Relocation assistance

Thursday work-from-home

Job summary

Lead Group in Perth is seeking a Senior Systems Engineer to join an innovative medical-device programme on a 12-month contract. The role spans electronics, firmware, software, and mechanical systems, with on-site work four days a week and Thursday work-from-home.

Relocation support is available for the right candidate. The successful applicant will own system-level architecture, requirements, risk management, V&V and support regulatory submissions, connecting clinical, quality and manufacturing

Qualifications

• Minimum 7 years' full-time engineering experience
• Strong medical device experience
• Experience across multidisciplinary products incorporating electronics, mechanical engineering, firmware/software and embedded systems
• Strong understanding of medical-device design controls
• Experience with requirements management and end-to-end traceability
• Strong understanding of risk management, verification and validation
• Experience with design transfer, configuration management and change control
• Ability to work effectively across Engineering, Quality, Regulatory and Manufacturing functions
• Strong analytical, technical problem-solving and communication skills

Responsibilities

• Lead systems engineering and technical integration across complex medical-device programmes
• Define and maintain user needs, design inputs, system requirements and interface requirements
• Own system-level architecture, functional decomposition and interface definitions
• Manage interfaces across electronics, firmware, software, mechanical components, sensors, manufacturing processes and clinical systems
• Maintain end-to-end requirements traceability through design, risk controls and V&V
• Identify system-level technical risks, dependencies, evidence gaps and integration challenges
• Lead cross-functional system integration and technical decision-making
• Work closely with Engineering, Clinical, Regulatory, Quality, Manufacturing and external partners
• Support design transfer, manufacturing scale-up and product lifecycle activities
• Provide systems engineering guidance and mentorship across multidisciplinary teams

Skills

Systems engineering

Technical integration

Requirements management

Risk management

Verification & Validation

Design controls

Regulatory submissions

Education

Bachelor’s degree or higher in a relevant field

Job description

Lead Group in Perth is seeking a Senior Systems Engineer to join an innovative medical-device programme on a 12-month contract. The role spans electronics, firmware, software, and mechanical systems, with on-site work four days a week and Thursday work-from-home.

Relocation support is available for the right candidate. The successful applicant will own system-level architecture, requirements, risk management, V&V and support regulatory submissions, connecting clinical, quality and manufacturing