Partnering with our business verticals and functions, the Strategy and Ventures team is assisting with their near- and longer-term growth strategies, as well as shaping our 2025 corporate strategy. We are also progressing ResMed’s corporate development agenda, focusing on growth through mergers and acquisitions (M&A), partnerships and new business creation.
At the outset of a 2017 innovation challenge, the concept for what is now Aria Free was born. Since that time, the Aria team has grown, and we’re looking for inspiring people to help us develop a little device we think can change therapy in a big way.
The Senior Systems Engineer will develop and define the engineering requirements and architecture to deliver a product in accordance with business and quality needs that can be delivered in a timely manner.
Reporting into the Product Development Lead, the Senior Systems Engineer works to deliver quality systems and documentation that meet the architecture and interface requirements. They will work very closely, and collaborate widely with the other disciplines to ensure that engineering specifications and architecture are delivered according to needs.
Let's talk about roles and responsibilities:
Collaborate with key stakeholders to define, develop and deliver system designs which can enable functionality as defined by the input requirements (performance, functional, human factors, safety and regulatory)
Define the architectural interfaces and ensure system components integrate successfully
Develop and maintain system specifications, ensuring full traceability of requirements
Lead development and implementation of the Risk Management File (RMF) at system and sub-system levels
Develop risk analysis in collaboration with key stakeholders and subject matter experts
Collaborate with key suppliers to ensure risk management activities are transferred to and being performed as required at the supplier
Maintain RMF throughout the lifecycle of the product
Support design transfer to suppliers for initial and ongoing production needs, including process development for product realization as necessary
Demonstrate commitment to meeting customer needs and feedback in order to progressively improve and innovate products and services
Work within Inova Labs’ quality system and stay abreast of evolving regulations/quality standards
Let's talk about skills and qualifications:
To be successful in this role, you should have the following:
Extensive knowledge of hierarchical systems design and decomposition
Expertise in risk management and understanding medical device development activities across a broad set of functions including quality and regulatory
Ability to communicate complex ideas effectively, both verbally and in writing
Exceptional analytical and quantitative problem-solving skills
Ability to work collaboratively in a team environment
Ability to work effectively with people at all levels in an organization
Proficiency with microsoft office and requirements traceability tools
High proficiency in product development and collaboration tools (JIRA and JAMA preferred)
To get us really excited, you will have a minimum of ten (10) years’ experience working in the medical device industry, including at least 5-7 years working in a systems engineering capacity.
Preference will be given to candidates with experience in manufacturing process engineering.
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!