Medical Device Technical Expert
- Experience Level
- Experienced (non-manager)
The Connected Health Ecosystems & Operations team is looking for an experienced System Engineer to lead the technical development of connected delivery systems including a medical device, mobile phone app and cloud based data storage.
The ideal candidate contributes to the development of complex medical devices and software as a medical device (SaMD) projects using state-of-the-art system engineering practices. This highly interactive role will work with cross-functional teams and support various development activities including requirement elicitation, system conceptualization, risk assessment, system verification and clinical validation.
The primary responsibilities of System Engineer include:
• Design and implement systems engineering approach to support the development and life cycle management of complex products and platforms in the areas of connected drug delivery devices, digital technologies, and SaMD.
• Demonstrate strong technical know-how at system level and guide the project teams for product development on defining pain points, user needs and technical design input requirements.
• Structure and visualise the system using systems modelling tools and integrate into a wider eco-system.
Utilize the system engineering tool for requirements management and translate user and business needs into system/sub-system requirements.
• Actively maintain and monitor the traceability from the requirements to the verification activities
• Implement risk management at systems level and co-ordinate risk management activities at component level.
• Write, implement and report on integrated system design verification and validation activities, especially in the area of end-to-end software testing.
• Be the representative of system engineering for the communications with cross-divisional teams, programs, and stakeholders.
• Author relevant design history files and GMP compliant documentations.
• Excellent problem-solving skills with an analytical mind.
• Systems and system of systems design using UML/SysML diagrams with good abstraction skills. Ability to decompose to device and software sub-systems. Domain modelling experience and linking to requirements definition and management a plus.
• Expertise in Web and Mobile application design, development and testing, as well as Cloud and IoT architecture and technologies for complex systems necessary, with application to SaMD.
• Detailed knowledge of using requirements management tools, previous experience of Polarion a plus.
• Prior experience of integrating and testing software modules developed by various teams is highly desirable.
• Knowledge of the best practices for software development: Methodology (Agile and V-Model) and tooling (CI/CD, Automation, Requirement Management, etc.).
• Experience with user experience, prototypes and proof of concept activities.
• Experience with cyber security, data privacy and system performance requirements.
• Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical/Electronic Engineering, Computer Science, or other relevant disciplines
• Minimal 5 years of experience in medical device development, or other highly regulated industries
• Strong communication skills for both technical discussions with dev team and also for alignments with business stakeholders
• Prior experience covering the medical device and/or SaMD product development from concept to commercial launch
• Experience working with the requirements and traceability management tools
• Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
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