For our customer located in Basel/St. Johann/Switzerland we are currently looking for (m/f) a Medical Device Senior Technical Expert
- Type of placement: 12 months
- Company: major Pharma company in Basel/St. Johann area
The Packaging and Device Development (PDD) department at our customer is looking for an experienced System Engineer. The System Engineer will contribute to the development of best-in-class system engineering practices and its implementation to medical device and/or software as medical device (SaMD) development projects. The preferred candidate has practical experience covering the product development to the life cycle management. The expert will work with cross-functional teams and support various development activities including system conceptualization, system requirements, risk assessment, system verification and validation.
The primary responsibilities of System Engineer include
- Design and implement system engineering approach to support the development and life cycle management of complex products and platforms in the areas of drug delivery devices, digital technologies, and SaMD.
- Utilize the system engineering tool 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
- Author relevant design history files and GMP compliant documentations
- Work within development projects with cross-functional teams, provide the system-level views and guide the projects to use the structured approach for product development
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplines
- Prior experience with design control processes, product lifecycle management in a GMP environment
- Expert knowledge in Systems Engineering and Risk Management
- Experience working with detailed requirements and traceability in order to author requirement documentations
- Knowledge in system functional modeling and/or programming ability using system modeling language (SysML) is highly preferred.
- Well-versed in medical product development, Quality Management System, and regulatory processes (ISO 13485, 60601, 62304)
Kindly be informed that this job offer is from our customer in Switzerland. Therefore we can only accept applications within the EU or applicants with Swiss work permissions.
Please attach your CV in Word format.
SimplyVision is looking forward to your application.