The Respiratory Care team is transforming the way in which Chronic Obstructive Pulmonary Disease (COPD) care is managed and delivered though our non-invasive ventilation and portable oxygen solutions. This means we identifying the pain points for patients, providers and payers and developing deeper insights into the unmet needs of COPD patients. We see a future in which resources and technology are less focused on the diagnosis and treatment of the disease and more oriented to prevention of COPD exacerbations and the slowing of disease progression.
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 and Section Leader.
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 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.
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.
Observe the principles of Occupational Health & Safety Legislation.
Let’s talk qualifications and experience:
Engineering degree with significant broad based, commercial experience.
Experience in New Product Development environment.
Proven effective communication / technical leadership to professional staff.
Significant System engineering experience and/or Project Management skills.
Engineering degree with post grad qualification and significant project management.
Medical device industry experience or related experience in a similarly regulated environment preferred
Formal training in project management, experiment methodology, Six Sigma, DFSS, or other related engineering topics.
Demonstrates a superior knowledge of regulations and customer specifications and their impact on design parameters (i.e. marketing, clinical, regulatory, manufacturing, quality, IP.
Joining 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!