System Engineer I
Tranzeal
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.
- 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.
- 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.
Vacancy posted 4 days ago
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