Let’s talk about Responsibilities:
- Establish, deliver and maintain System Requirements and Risk Analysis encompassing Patient, Marketing, Quality and Regulatory needs. Ensure full traceability of the System Requirement and Risk Analysis.
- Work with engineering disciplines to translate user requirements and usage scenarios into system and design specifications to ensure product achieves performance, functionality and reliability.
- Defining the architectural interfaces and ensuring the system components will integrate successfully.
- Represent systems engineering at the XFT. Identify/Evaluate design alternatives and technical issues with the engineering disciplines, and review issues with the XFT where required.
- Define and ensure the system components will integrate successfully to appropriate quality levels, ensuring full traceability of requirements.
- Interface with project stakeholders to ensure that the system objectives are balanced with overall project objectives.
- Ensure rigorous documentation for all phases of development, including design specifications, verification test plans, and project schedules.
- Ensure risk of non-compliance and related business risks are mitigated at every stage of the development process. Identify, define and communicate compliance requirements for all aspects of projects. Develop measures, feedback and reporting mechanisms for Senior Management.
- Ensuring that ResMed Systems Engineering Processes are adhered to and recommend updates to processes where appropriate.
- Collaborate with V&V department to define the Verification and Validation plan to demonstrate that product meets technical specification and each user requirement and usage scenario.
- A commitment to continuous improvement and a strong desire to improve the activity of product development.
- Develop and support the product development documentation management system, procedures and policies to ensure that products are developed to meet ResMed’s performance & quality expectations.
- For Senior role, as part of Technical Competencies, provide technical mentoring & training to the broader Product Development Group as required on Systems Engineering. Maintain a broad knowledge of company products, competitors, and customer’s needs.
Let’s talk Qualifications and Experience:
- Engineering degree with post graduate qualification, significant broad based commercial knowledge.
- Experiences working in New Product Development environment and significant System engineering skills.
- Formal training in experiment methodology, Six Sigma, DFSS, or others.
- It would be advantageous to have experiences within the medical industry and Regulatory (e.g. FDA, MDD/MDR, etc.) related experience.
- Able to work independently.
- Strong communicator.
Establish, deliver and maintain System Requirements and Risk Analysis encompassing Patient, Marketing, Quality and Regulatory needs.