Associate Systems Engineer - Software

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

Job summary

Planet Pharma seeks an Associate Systems Engineer - Software to drive software product definition, requirements, risk analysis, and verification/validation to meet IVD standards. This role supports cancer diagnostics through advanced testing automation and global instrument deployment.

The ideal candidate has a Bachelor's degree in Engineering, Biomedical Sciences, or related field with 0-2 years' experience, strong systems thinking, and familiarity with FDA/ISO regulatory environments.

Qualifications

• 0-2 years of engineering experience in a regulated diagnostics environment.
• Knowledge of software integration, requirements, risk, and testing lifecycle.
• Familiar with FDA/ISO standards for diagnostic products.
• Strong analytical and problem-solving skills with cross-functional collaboration.

Responsibilities

• Apply Systems Engineering to SW product definition and requirements.
• Manage software requirements, risk analysis, configuration, defects, and V&V.
• Research industry trends and competitive software features.
• Collaborate with R&D, Marketing, Operations, Quality, and Regulatory teams.
• Engage with business leaders and Voice of Customer to align solutions.
• Analyze complex technical challenges and present informed decisions.

Skills

Software integration

Software testing

Requirements engineering

Risk management

Verification and validation

Tradeoff analysis

Regulatory familiarity

Education

Bachelor's degree in Engineering, Biomedical Sciences, or related technical field

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