Systems Engineer Software
Share
Job Location:
Tucson, AZ - USA
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
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
**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.
Key Skills
- Academics
- Hardware & Networking
- ASP.NET
- Business Operations
- Barista
- ERP
