Associate Systems Engineer – Software

Planet Pharma; Tucson (AZ); On-site; USD 55,000 - 69,000; Full time

Job summary

Planet Pharma in the United States seeks an Associate Systems Engineer – Software to drive software product definition, requirements, architecture design, and risk analysis for IVD diagnostics. This role supports testing automation and ensures FDA/ISO compliance while advancing cancer diagnostics.

The position emphasizes collaboration with R&D, Quality, Regulatory, and Operations, plus hands-on verification/validation, configuration management, and risk mitigation to deliver robust software

Qualifications

• Educational background with a Bachelor's degree in Engineering, Biomedical Sciences, or related field.
• Experience: 0-2 years in systems engineering or related area.
• Familiar with software requirements, risk analysis, and verification/validation.

Responsibilities

• Apply Systems Engineering to software product definition, requirements, risk analysis, and testing.
• Manage software requirements, risk analysis, configuration, defect tracking, and verification/validation.
• Research trends and competitive products to differentiate software.
• Collaborate with R&D, Marketing, Operations, Quality, and Regulatory teams to align solutions.
• Engage with stakeholders to ensure solutions meet customer needs.
• Analyze complex technical challenges and present informed solutions.

Skills

Systems engineering

Regulatory knowledge

Analytical thinking

Communication skills

Software testing

Education

Bachelor's degree

Job description

Seeking an Associate Systems Engineer – Software 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 0-2 years of experience.
• 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

• Experience: 2 years of experience
• 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.

Pay Rate Range: $40-50/hr depending on experience