Systems Engineer

Description :

As a member of our R&D team, the Systems Engineer will drive assay and software integration and testing practices in projects, including defining requirements, designing system architectures, and implementing solutions to meet IVD standards. This individual will take ownership of project deliverables and facilitate the decision-making process with well-considered tradeoffs.

Responsibilities include :

System Lifecycle Management : Apply broad knowledge and skill-sets from Systems Engineering, focusing on the software integration and testing stages of the system lifecycle.

Industry and Technology Analysis : Research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for software differentiation and creative solutions.

Cross-functional Collaboration : Work closely with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with organizational objectives and regulatory requirements.

Customer-Focused Innovation : Engage with business leaders and VoC representatives to ensure technical solutions align with customer needs and market demands, facilitating stakeholder discussions to prioritize software features and enhancements.

Technical Problem Solving : Analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address software integration and testing challenges.

Project Execution : Execute project deliverables specific to software requirements, risk analysis, configuration management, defect management, and verification and validation in the company-specific tool.

Who You Are

Educational Background :

Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master's degree with 2 years of experience, or a PhD).

Systems Engineering Expertise : Demonstrated knowledge of systems engineering principles, specifically in software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.

Regulatory Familiarity : Experience working in a regulated environment, with familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products.

Strategic Mindset : Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD.

Preferred

Specialized Skills : Deep knowledge in software reliability, manufacturability, and usability.

Leadership and Communication : Proven ability to build authority and accountability within a team, with strong collaboration and communication skills.

Organizational Skills : Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities; capability to formulate and solve problems, and complete work in a timely, accurate, and thorough manner.

Assay Development : Familiarity with the assay development process.

Technical Tools : Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark / LucidChart.

Advanced Knowledge : Advanced understanding of software engineering, electronics, electro-mechanical systems, information technology, and basic chemistry.