Client is seeking an Associate Systems Engineer - Software to drive software product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards. This role focuses on advancing cancer diagnostics through state-of-the-art testing automation, providing over 250 cancer tests and associated instruments globally.
RESPONSIBILITIES
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 0-2 years of experience.
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
Experience: 2 years of experience
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.