Experience: 5-7 Years
Sector: System Administrator
Senior Systems Engineer (Medical Device)
Our client developed an implantable cardiac monitoring device for patients with heart failure. It’s a first of its kind in the market, with multiple patents protecting the IP. While the implant and core sensing technology has been established, the next step to unlock this huge market is to deliver on the Patient experience. i.e., to fit the technology into the Patient’s lifestyle and behaviours, akin to how Dexcom have disrupted the diabetes market with continuous glucose monitoring.
The Senior Systems Engineer will provide technical leadership in defining system requirements and assuring that these requirements are met.
- Leadership of requirements definition and assurance across all elements of our system and functions
- Establishment of user needs, systems requirements and architecture, verification planning and creation of documentation in the quality management system
- Participate in driving systems engineering activities across a novel system including implant, delivery system, mechanical, electronics, firmware, communications, mobile app, cloud architecture, web application and algorithms
- Ownership of requirements flow down and traceability table
- Develop project plans, milestones, actions etc. and manage status and tracking
- Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation
- Train, develop and lead R&D engineers and other technical staff in systems engineering.
- Provide assistance and support to other departments including Manufacturing, Quality and Regulatory as required.
- Engage with the QMS to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives
Experience & Education
- 6+ years previous experience in systems engineering a regulated environment with knowledge of medical device product development
- Given the complexity of our system (which includes mechanical, electronics, mobile app, web app) we would favour a candidate that is experienced in the use of PLM tools and requirements management software (such as Jama)
- Record of accomplishment in managing complex projects with multiple sub systems
- Minimum Bachelor’s Degree in Engineering related discipline (Biomedical or equivalent);
- Systems engineering experience including hardware, software and mechanical sub-systems
- Masters Qualification in Engineering in Biomedical or equivalent
- Demonstrate an analytical, systematic approach to problem solving and good attention to detail.
- Have strong interpersonal and communications skills
- Be innovative & creative, show appetite to continually learn and explore new ideas.
- Be a self-starter and use his/her own initiative in most situations.
- Be a strong team player with proven capability to work well in a fast paced, dynamic environment.
- Have an ability to manage multiple tasks and adapt to changing, fast paced environment
- High level computer skills including MS Office Suite
- Familiarity with Web based productivity tools, such as Jira/Confluence or equivalent.
- Understanding or ability to navigate Mobile, Web & Cloud technologies. e.g., AWS, databases, mobile eco-system, etc.