Our client is a global leader within the Pharmaceutical industry. On behalf of our client, Swisslinx is looking for a technical Systems Engineer to join a 6 month contracting opportunity with a possible extension.
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.
- 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.
- 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.
- 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.
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical/Electronic Engineering, Computer Science, or other relevant disciplines.
- Experience in systems design using UML/SysML diagrams with good abstraction skills.
- Ability to decompose to device and software sub-systems.
- 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.
- 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.
- Minimal 5 years of experience in medical device development, or other highly regulated industries.
- 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).