Experience writing SW requirements and completing risk analysis. Ability to work independently and cross-functionally with many different groups to solicit needs and complete trade off analyses. Experience in a regulated medical device industry.
The Position: Systems Engineer (SW Requirements and Risk)
Location: Tucson, AZ
Long Term Contract
We are seeking a Systems Engineer 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 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.