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Pauwels Consulting is a Belgian consulting firm with more than 520 experts in engineering, life sciences and IT. We offer consulting, project management and recruitment services to leading companies in Belgium and beyond. We have offices in Belgium, France, Germany and Switzerland (https://www.pauwelsconsulting.com/about/contact/) .
Cloud Software Engineer
We are looking for a Specialist Software Engineer to strengthen our client's Value Based Solutions & Innovation team. In this team we focus on the scale up, design, development and operation of European digital services and solutions with real patient impact. As such, we operate multiple CE marked software medical devices (SaMD) that are classified under MDD/MDR. The Specialist Software Engineer will be responsible for the software design, development, and operation of these SaMD.
The successful candidate oversees our cloud infrastructure as well as our external vendors. Day-to-day, this means developing the software on Amazon Web Services. Working with internal and external partners both locally and remotely. Liaising between external vendors and internal stakeholders such as Commercial, IT, medical information, compliance, Data Privacy, Quality, Regulatory Affairs, Global Patient Safety, and product complaints teams. All with the sole purpose to ensure our client's digital solutions are serving patients to the fullest extent.
The Software Engineer ensures that these systems comply with corporate regulatory, compliance, quality, and business requirements with support from relevant compliance and quality assurance teams. The engineer is responsible for the product and process artifacts and documentation of the SaMD software development lifecycle (standard operating procedures, design history file, user requirements, design, change control etc.) and ensuring these are up to date in Amgen’s Quality Management System. This includes providing support to the System Owner through assessment, review and approval of change management documentation.
The ideal candidate is analytical, methodical, and accurate. The ideal candidate has experience in the regulated environment of life sciences, with a demonstrable understanding of MDD/MDR (preferred), GMP, or another relevant regulation. Experience with software development in JSON/XML is required.
- Experience with Amazon Web Services including API gateway, Lambda, S3, IAM, and DynamoDB
- Experience with JSON/XML programming
Strong communicator and service minded:
- Liaises between external vendors and various internal teams to gather requirements for customer and/or infrastructure support
- Leads project discussions to implement services
- Leads stakeholder discussions communicating project status and reconciling changing business requirements with service delivery
- Acts with a customer service-mentality serving internal and external customers by driving progress (e.g. finding the right people or driving for clear decision making)
- Can present technical work to external and internal auditors, as required
- Can act as 1st and 3rd level support for software medical devices that could include escalating issues with vendors or engaging internal teams to resolve issues
- Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
- Anticipates and prevents potential problems
- Handles diverse scope of issues that require evaluation of a variety of factors including current business trends
- Independently develops solutions that are thorough, practical and consistent with functional objectives
Bachelor’s degree or equivalent combination of education and experience
Fluency in written and spoken English. Dutch is not a requirement
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
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45 days left to apply
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