The task will include working in the foundation of our quality management system in the entire product lifecycle. To create, update or improve policies, standard operating procedures and templates in IDEA for CON and/or Veeva systems consideridering continuous improvements that comply with regulations, maintain patient safety first while allowing evolutionary development.
• Consult multiple cross-functional teams 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 the 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 the 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 and align with relevant Stakeholders and Engineering Chapter Goals based on the experience of the contractor.
• Bachelor’s or Master’s degree in Bioengineering, Biomedical Engineering, Computer Science or similar
• English working proficiency and communication skills (verbal and written), German is a plus
• Several years experience including product development and operations related to SaMD classified as class 2 and/or class 3
• Demonstrated applied expertise in EU Medical Device Directives and FDA design control requirements (21 CFR 820.30) as applied to medical device software and medical device regulations including ISO 13485, ISO 14971, and IEC 62304
• Experience in the creation and implementation of system engineering Standard Operating Procedures with particular attention in the addition of exploratory prototyping phases, integrating risk management, Human Factor/Usability Engineering, cybersecurity and medical device development lifecycle
• Know-How in the area of software testing such as manual, automated, smoke, black box, regression, system and integration testing
• Comfortable with large projects in source control and continuous integration and delivery
• Knowledge in at least one of the following technologies: Java (Spring), TypeScript, Python, Scala, PostgreSQL, Go
• Knowledge of development stack tools, e.g. Git, Docker, Kubernetes, OpenShift, Jenkins, Terraform, AWS is a plus
• Experience developing cross-platform and native mobile applications is a plus
• Knowledge of infrastructure and documentation as code is a plus
Location: Ingelheim and Remote
Project start: February 2022
Duration: 7 months
Availability: ~ 40 hours/week