Associate Systems Engineer - Software

Responsibilities: System Lifecycle Management: Apply Systems Engineering to software 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 to identify opportunities 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 Voice of Customer (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 AreEducational Background: Bachelor's degree in Engineering, Biomedical Sciences, or a related technical field, with 0–2 years of experience. Systems Engineering Expertise: Demonstrated knowledge of software integration and testing, including requirements engineering, trade-off analysis, risk management, configuration management, and verification/validation. Regulatory Familiarity: Experience in a regulated environment and familiarity with FDA, ISO, and other relevant diagnostic product standards. Strategic Mindset: Interest in innovative technologies and an understanding of the in vitro diagnostics (IVD) competitive landscape.

Experience: 2 years of relevant experience. Specialized Skills: Deep knowledge of software reliability, manufacturability, and usability. Leadership and Communication: Proven ability to establish authority and accountability within a team, along with strong collaboration and communication skills. Organizational Skills: Excellent organizational skills, with the ability to evaluate, prioritize, and manage multiple projects efficiently.