System Engineer (Medical Device/IVD) Job at Pharmaceutical Company, Tucson, AZ

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  • Pharmaceutical Company
  • Tucson, AZ

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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