Consulting Engineer (m/f/n)
The scope of services includes the following tasks, to be independently performed by the external contractor:
- The task will include working in the foundation of our quality management system in the entire product lifecycle.
o To create, update or improve policies, standard operating procedures and templates in IDEA for CON and/or Veeva systems considering continuous improvements that comply with regulations, maintain patient safety first while allowing evolutionary development. This will be reviewed by our internal team at BI.
- Consult multiple cross-functional teams in BI X to review, propose improvements on the delivery of development and operations of products according to specified methodology and best practices in the industry to achieve a scalable codebase even with larger user-bases, and is easy to understand, maintain and extend.
- Review if Software related to Medical Devices (ISO13485, IEC62304, IEC14971, IEC62366, MDR, GMP, etc) is in alignment with BI guidelines/standards and identify areas which need to be improved.
- Review the provision of product alongside with its technical documentation according to internal and external regulations, identify gaps, communicate those with product team to mitigate them.
- Review that Software related to Medical Devices products comply with technical architecture (technology, interfaces, data storage ?), identify gaps, communicate those with product team to mitigate them.
- Assess and review the compatibility of development stack with BI standards and interoperability with relevant internal systems, tools and infrastructure, identify gaps, communicate those with product team to mitigate them.
- Consult about the development and change management of Software related to Medical Devices development can retain agility and allow for competitive timelines based on the contractor's experience
- Consult on to the strategy for Medical Device Software with regards to technology and development at BI X and BI align with relevant Stakeholders and Engineering Chapter Goals based on the experience of the contractor.