Systems Engineer - Software
TalentBurst, Inc.
Tucson, AZ
Job ID: ROCGJP00039034
Location: Tucson, AZ
Duration: 08 months contract ( Possibility of extension)
Job Description:
**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:
Tissue Diagnostics is 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.
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About the Company
TalentBurst, Inc.
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!