TechOne Staffing
Systems Engineer (SW Requirements and Risk)
location: Tucson AZ
Duration: 1 year extendable
Key Points **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
Client 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.
MUST-HAVE Qualifications
Bachelors degree in Engineering Biomedical Sciences or related technical field with 4 years of experience (or Masters 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.
Good-to-Have skills:
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.
location: Tucson AZ
Duration: 1 year extendable
Key Points **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
Client 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.
MUST-HAVE Qualifications
Bachelors degree in Engineering Biomedical Sciences or related technical field with 4 years of experience (or Masters 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.
Good-to-Have skills:
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.