Job Description

GeneProof is seeking a System Engineer to develop In-Vitro-Diagnostic (IVD) medical devices. This role focuses on designing, developing, and managing a complete system, ensuring all components work together effectively while meeting regulatory requirements. This involves defining requirements and specifications, developing architecture, conducting verification and validation, and managing risks throughout the product lifecycle.

The GeneProof System Engineer will be responsible for coordinating the development and integration of the myCROBE IVD device, including hardware, software, and consumables (PCR kits, reagents). The System Engineer shall ensure technical coherence across development teams and shall collaborate with Regulatory and Quality associates on IVDR and FDA compliance. 

Key Responsibilities

• Requirements Management: Defining, documenting, and managing system requirements, including user needs, functional requirements, and performance specifications. 
• Systems Architecture: Developing and documenting the system architecture, including hardware, software, and interfaces, ensuring a cohesive and functional design. 
• Verification and Validation: Developing and executing verification and validation plans to ensure the system meets all requirements and regulatory standards. 
• Risk Management: Identifying, assessing, and mitigating potential risks throughout the product lifecycle, including design, manufacturing, and clinical use. 
• Intra Team Collaboration: Working closely with cross-functional teams including hardware engineers, software engineers, test engineers, quality assurance, and regulatory affairs, to ensure a successful product development process
• Documentation: Maintaining comprehensive documentation, including design specifications, verification reports, trace matrices and risk assessments. 
• Problem Solving: Identifying and resolving technical issues and challenges that arise during the development and testing phases.
• Cost and Schedule Management: Considering cost and schedule constraints during the design and development process. 
• Regulatory Compliance: Working with Regulatory and Quality to ensure compliance with relevant regulatory standards and guidelines, such as those from the FDA, IVDR and IEC.
• Coordinate the development of subsystems (HW, SW, assays, application logic) to meet defined functional and regulatory requirements. 
• Define and manage system interfaces between individual device subsystems 
• Provide technical leadership for integration activities – oversee assembly, testing, and debugging of prototypes and device versions. 
• Collaborate with application specialists to gather requirements and test system performance for new PCR assay kits 
• Assesses system throughput and identifies opportunities for future improvements
• Support transfer to manufacturing and final system validation. 
• Ensure system documentation according to internal and regulatory standards. 

Requirements

• University degree in a technical or scientific field. 
• 5 or more years’ experience in the development or integration of IVD devices or laboratory instruments within a regulated framework. 
• Ability to read technical documentation, schematics, and HW/SW specifications. 
• Communication Skills: Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams including Hardware, Software, Chemistry. 
• Knowledge of systems engineering principles, integration testing, traceability. 
• Knowledge of Medical Device Regulations: Familiarity with relevant regulatory standards and guidelines, such as those from the FDA, IVDR and IEC.
• Analytical thinking and problem-solving orientation. 
• English proficiency (minimum B2) for working with technical documentation and communication. 

Key Internal Interfaces 

• HW/SW Development Team 
• PCR Kits and Chemistry Development 
• Application and Product Specialists 
• Regulatory Affairs and Quality Assurance (QA/RA) 
• Manufacturing and Service 
• Project Management 

Místo výkonu práce: Brno (Dolní Heršpice, budova Vienna Point) 
 

Zaujala Vás tato pozice? Profesní životopis zasílejte na e-mail: job@geneproof.com  Do předmětu uveďte hledanou pozici "System Engineer". 

Děkujeme za Váš zájem o společnost GeneProof a.s.