Associate Systems Engineer - Software

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Associate Systems Engineer – Software 
Employment Type: Contract
Industry: Medical Diagnostics / Healthcare Technology
Experience Level: Entry-Level to Early Career (0-2 Years)
Help Advance the Future of Diagnostic Software
Join an innovative team developing software solutions that support advanced diagnostic technologies used in cancer testing and pathology laboratories worldwide. As an Associate Systems Engineer – Software, you will contribute to the development of software-driven diagnostic systems by helping define product requirements, evaluate risks, support system architecture, and ensure solutions meet industry and regulatory standards.

This is an excellent opportunity for an early-career engineer who is passionate about healthcare technology, software systems, and developing solutions that help improve patient outcomes through advanced diagnostic testing.
Position Overview
The Associate Systems Engineer – Software will support the software development lifecycle by applying systems engineering principles to product definition, requirements management, risk analysis, verification, validation, and software integration activities. The role involves close collaboration with engineering, quality, regulatory, operations, and business teams to deliver high-quality software solutions within a regulated medical device environment.
Key Responsibilities Systems Engineering & Product Development

• Apply systems engineering methodologies to software product development activities.
• Support software product definition, requirements development, system architecture activities, and solution implementation.
• Participate in requirements engineering, risk analysis, system verification, and validation efforts.
• Contribute to software integration and testing activities throughout the product lifecycle.

Project Execution & Lifecycle Management

• Support management of software requirements, configuration controls, and defect tracking processes.
• Assist with risk management and design control activities.
• Participate in software verification and validation (V&V) activities to ensure product quality and compliance.
• Help maintain project documentation and support regulatory readiness.

Technology & Market Analysis

• Research emerging technologies, industry trends, and competitive software solutions.
• Evaluate opportunities to improve product performance, reliability, and differentiation.
• Support technical assessments and tradeoff analyses for software-based systems.

Cross-Functional Collaboration

• Partner with Engineering, Research & Development, Marketing, Operations, Quality, and Regulatory Affairs teams.
• Support alignment between technical solutions, business objectives, and customer needs.
• Collaborate with stakeholders to ensure successful project execution and product development.

Technical Problem Solving

• Analyze complex technical challenges and contribute to solution development.
• Support data-driven decision-making by presenting findings, recommendations, and technical analysis.
• Assist with identifying opportunities for process and product improvements.

Required Qualifications Education & Experience

• Bachelor's degree in Engineering, Biomedical Sciences, Computer Science, Software Engineering, or a related technical discipline.
• 0-2 years of relevant professional experience.

Technical Knowledge

• Understanding of systems engineering principles and software development processes.
• Knowledge of:
  • Requirements engineering
  • Risk management
  • Tradeoff analysis
  • Configuration management
  • Software integration and testing
  • Verification and validation (V&V)
• Interest in software products used within regulated industries.

Regulatory & Industry Awareness

• Familiarity with regulated development environments.
• Understanding of FDA, ISO, or similar industry standards related to medical devices, diagnostics, or healthcare technology.

Preferred Qualifications

• Approximately 2 years of relevant industry experience.
• Knowledge of software reliability, manufacturability, and usability principles.
• Strong organizational skills with the ability to prioritize and manage multiple projects simultaneously.
• Excellent written and verbal communication skills.
• Demonstrated ability to collaborate effectively across cross-functional teams.
• Ability to establish credibility, accountability, and influence within a project team environment.
• Interest in emerging healthcare technologies and the in vitro diagnostics (IVD) industry.

Why Join This Opportunity?

• Contribute to innovative diagnostic technologies that help support cancer detection and patient care.
• Gain valuable experience in systems engineering, software development, and regulated product environments.
• Work alongside multidisciplinary teams across engineering, quality, regulatory, and business functions.
• Develop expertise in the growing fields of healthcare technology, diagnostics, and medical device software.

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