Develop the engineering specifications and architecture to deliver a product in accordance with need that can be delivered in a timely matter. Responsible for Systems Engineering deliverables of multiple projects in a timely manner. Provide clarity and communication on desired System Level deliverables. Part of the XFT responsible for the delivery of the product to manufacturing within the required timelines.

Let’s talk about Responsibilities

Define design structure to provide desired functionality per product and user requirements and Regulatory Standards for applicable regions.Work with engineering disciplines to translate user requirements and usage scenarios into system and design specifications to ensure product achieves performance, functionality and reliability.Deliver and maintain Functional / System Specifications. Ensure full traceability of requirements.Identify and evaluate technical design alternatives to achieve desired functionality with approval from XFT.Resolve technical issues with the engineering disciplines and review issues with the XFT where required. Represent systems engineering at the XFT.Define and ensure the system components will integrate successfully to appropriate quality levels.Interface with other project stakeholders to ensure that the system objectives are balanced with overall project objectives.As part of Technical Competencies provide technical mentoring & training to the broader Product Development Group as required on Systems Engineering.Complete and maintain the system Risk Analysis.Ensure rigorous documentation for all phases of development, including design specifications, verification test plans, and project schedules.Work 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.Ensure risk of non-compliance and related business risks are mitigated at every stage of the development processIdentify, 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.Develop and support the product development documentation management system and procedures and policies to ensure that products are developed to meet ResMed’s performance & quality expectations.A commitment to continuous improvement and a strong desire to improve the activity of product development.Maintain a broad knowledge of company products, competitors, and customer’s needs.Supporting Manufacturing for initial and ongoing production needs.Supporting Sustaining engineering for released products.

Let’s talk about Qualifications and Experience

Required:

Proficiency in MS Word, Excel and PowerPoint.Proficiency with Objective document management softwareAchievement oriented. Self-starter.Innovative. Explorative. Highly intelligent. ResourcefulIdentifies root cause through careful and systematic analysis of product development issues RequiredEngineering degree with significant broad based, commercial experienceExperience in New Product Development environmentProven effective communication / technical leadership to professional staffSignificant System engineering experience and/or Project Management skills

Preferred:

Engineering degree with post grad qualification and significant project management.Medical device industry experienceDemonstrates a superior knowledge of regulations and customer specifications and their impact on design parameters (i.e. marketing, clinical, regulatory, manufacturing, quality, IP).

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