TI
Systems Engineer - Software
Tranzeal Inc.
- 🇺🇸 United States
- On-site
- 10 months ago
- Risk Management
- Configuration Management
10 months ago
Not enough detail in this posting to match
--System Lifecycle Management: Apply Systems Engineering to SW product definition, requirements, risk analysis, and testing.
--Project Execution: Manage software requirements, risk analysis, configuration, defect management, and verification/validation.
--Industry and Technology Analysis: Research trends, emerging technologies, and competitive products for software differentiation.
--Cross-functional Collaboration:Work with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment.
--Customer-Focused Innovation: Engage with business leaders and VoC representatives to align technical solutions with customer needs.
--Technical Problem Solving:Analyze complex technical challenges, present solutions, and facilitate informed decision-making.
Who You Are:
Educational Background: Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or Master's with 2 years, or PhD).
Systems Engineering Expertise: Demonstrated knowledge in software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification/validation.
Regulatory Familiarity:Experience in a regulated environment, familiar with FDA, ISO, and other relevant diagnostic product standards.
Strategic Mindset: Interest in innovative technologies and understanding of the IVD competitive landscape.
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, capable of evaluating, prioritizing, and managing multiple projects efficiently.
Systems Engineer - Software · Tranzeal Inc.