Beschreibung
To revolutionise medical devices and introduce connectivity and digitalisation to them, I am recruiting for an ambitious and motivated Systems Engineer/Software Architect who will develop software as medical device (SaMD) projects using state of the art system engineering practices. You will bring your past experience and knowledge of medical device regulations to develop exciting new devices and software.Responsibilities:
- Design and implement system 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 development team to use structured system engineering approach for product development
- Utilize the system engineering tools for requirement 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 - Be the representative of system engineering for the communications with cross-divisional teams, programs, and stakeholders
- Manage external vendors for development and lead the technical discussions with the vendors
- Author relevant design history files and GMP compliant documentations
Excellent problem-solving skills
Requirements:
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines
- Software and System design using UML diagrams with good abstraction skills.
- Expertise in Web and Mobile application design, development and testing.
- Experience with Cloud and IoT architecture and technologies for complex systems.
- Knowledge of best practices for software development: Methodology (Agile and V-Model) and tooling (CI/CD, Automation, Requirement Management, etc.).
- Experience with research, prototypes and PoC activities.
- Experience with cyber security and performance requirement.
- Minimal 5 years of experience in medical device, or other highly regulated industry
- Prior experience covering the medical device or SaMD 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)
- Strong communication skills to both lead the technical discussions with vendors and also align with internal stakeholders to drive decisions
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.