Job Description

Job Description

Overview

Seeking a Systems Engineer to lead software product definition, requirements, and risk analysis for regulated medical device/IVD systems. This role focuses on system architecture, documentation, and cross-functional collaboration to support advanced diagnostic automation.

Key Responsibilities

• Software Requirements & Risk: Define software requirements, perform risk analysis, and support system-level design.
• System Lifecycle Management: Support configuration management, defect tracking, and verification/validation activities.
• Technical Documentation: Create and maintain requirements, risk files, and supporting technical documentation.
• Cross-Functional Collaboration: Work closely with R&D, Quality, Regulatory, Operations, and Marketing teams.
• Technology Research: Analyze industry trends and emerging technologies to guide product improvements.
• Problem Solving: Support decision-making by evaluating complex technical challenges and proposing solutions.

Required Qualifications

• Education: Bachelor’s degree in Engineering/Biomedical/related field + 4 years experience
• (or Master’s + 2 years, or PhD).
• Industry Experience: Background in regulated medical device development.
• Core Skills:
• Writing software requirements
• Conducting risk analysis
• Systems engineering methods (trade-off analysis, V&V, configuration mgmt.)
• Regulatory Knowledge: Familiar with FDA, ISO, and IVD standards.
• Collaboration: Able to work independently and cross-functionally.

Preferred

• Experience in software reliability, usability, and manufacturability.
• Strong communication and leadership skills.
• Ability to manage and prioritize multiple technical projects.

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