System Solutions Engineer – Medical Device Certification

Company Description

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. 

Job Description

System Solutions Engineer will be responsible for analyzing our operational procedures and systems tools and delivering customised solutions to enable more efficient and user-friendly workflows.

You will work as part of the SGS Notified Body 1639 IVDR team, which carries out certification of in-vitro diagnostic medical devices under European regulations (IVDR 2017/746). You will support a growing, global team of regulatory professionals. Your work will elevate the productivity of the team, increase the process maturity and contribute to the business intelligence of the organisation by delivering actionable metrics and insights.

More specifically, you will:

• Analyze and understand the operational procedures and systems tools currently in use.
• Architect solutions to effectively meet the business needs, satisfy regulatory requirements and provide streamlined user workflows.
• Determine the most effective technologies to realise these tools, using either SGS internal platforms, customizable platforms from external vendors and/or appropriate software libraries.
• Develop tools using an iterative approach, coordinate testing of prototypes by the end users and deploy tools to the team.
• Develop and deliver documentation and user training materials.
• Directly provide user support during development and empower other team members to
• Project manage the development of these tools by defining development roadmaps and providing regular status updates.

Qualifications

Please submit English CV for the application

Essential:

• Proven experience as an System Solutions Engineer or similar role.
• Bachelor’s degree in Computer Science, Software Engineering, or related field
• Proficiency in at least one programming language and tools/libraries relevant for development of multi-user database-backed applications.
• An understanding of relational databases, including database schema design, data normalisation and writing complex queries.
• Proven ability to understand user needs and to translate them into creative solutions
• Ability to prioritise rapid development of prototypes while ensuring a stable and scalable foundation for future development
• Knowledge of best practices for safeguarding cybersecurity, data integrity and stewardship of sensitive customer data.
• Ability to work independently in a structured manner, while ensuring effective stakeholder communication.
• Fluent in English, with excellent communication skills

Desirable:

• Prior experience in developing internal business tools for organisations.
• Knowledge of process improvement methodologies.
• Knowledge of data science / data analytics for deriving key metrics and business intelligence insights. Ability to analyse and derive insights from natural language data would be beneficial.
• Prior experience working withing the context of regulatory affairs and certification, and/or under a regulated quality management system.

Additional Information

• We provide remote working environment.

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