Systems Engineer; Software & Risk

Systems Engineer (Software Requirements & Risk)

We are seeking a Systems Engineer to define and manage software requirements, product definition, and risk analysis for advanced IVD products that power over 250 cancer tests worldwide. This role supports the development of innovative diagnostic systems through strong cross‑functional collaboration and systems engineering expertise.

• Expertise in writing software requirements, defining product specifications, and performing risk analysis to support product delivery
• Drive software product definition, requirements, risk management, and testing across the full system lifecycle
• Manage configuration, defect tracking, and verification/validation activities
• Conduct trade‑off analyses and support technical decision‑making
• Collaborate with R&D, Quality, Regulatory, and Marketing teams to align on technical and business goals
• Contribute to customer‑driven innovations by translating needs into actionable technical solutions

• Bachelor’s degree in Engineering, Biomedical Sciences, or related field (Master’s or PhD preferred)
• 4+ years of experience in software systems engineering or product development
• Proven experience writing software requirements and performing risk analysis
• Background in a regulated medical device or IVD environment (FDA/ISO standards)
• Strong analytical, communication, and collaboration skills
• Familiarity with systems integration, verification/validation, and configuration management

Associate

Contract

Writing/Editing, Analyst, and Engineering

Medical Equipment Manufacturing and Pharmaceutical Manufacturing