À propos
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. This tailored job description is focused on a Systems Engineer specializing in software integration and testing within the exciting and innovative field of cancer diagnostics.
Compétences idéales
- Risk Management
- Software Testing
- Systems Engineering
Expérience professionnelle
- System Engineer
- Biomedical Engineer
Compétences linguistiques
- English
Avis aux utilisateurs
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