Systems Engineer - Software

Employment Type: W2 / 1 Year Contract with possibility of extensions!
Pay Rate: $39.00 – $42.00 per hour (Based on experience, paid weekly)
Benefits: Medical, Dental, Vision, and Life Insurance
Note: This is an onsite position.

This range is provided by BEPC Inc.

- Business Excellence Professional Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$39.00/hr - $42.00/hr

BEPC, Inc. is actively seeking a Systems Engineer – Software to support our client, a global leader in cancer diagnostics, located in Tucson, AZ. This role focuses on software product definition, requirements development, system design, and risk analysis for regulated medical device systems used in diagnostic applications.

The ideal candidate will have experience in software requirements engineering, risk management, and system-level analysis, with a strong understanding of IVD and FDA-regulated environments. This position offers an exciting opportunity to advance innovations in automated cancer testing and life‑saving diagnostic technologies.

• System Lifecycle Management: Apply Systems Engineering principles to software product definition, requirements documentation, risk analysis, and system validation.
• Software Product Development: Author, review, and manage software requirements
  , ensuring traceability and compliance with quality and regulatory standards.
• Risk & Compliance Management: Conduct software risk analyses in alignment with FDA
  , ISO 13485
  , and IEC 62304 standards.
• Cross-Functional Collaboration: Work collaboratively across R&D, Quality, Regulatory, Operations, and Marketing to translate business and technical needs into actionable system requirements.
• System Architecture Design: Support the design of robust, scalable, and compliant software architectures.
• Trade‑Off Analysis: Perform design and performance trade‑offs to optimize software functionality, reliability, and usability.
• Testing & Validation: Participate in verification and validation (V&V) activities to confirm compliance with system and regulatory requirements.
• Continuous Improvement: Identify and implement process improvements to streamline development, testing, and documentation workflows.
• Technical Leadership: Serve as a subject matter expert in systems and software integration, providing mentorship and guidance on risk management and compliance.

Education:

• Bachelor’s degree in Engineering, Biomedical Sciences, Computer Science, or a related technical field with at least 4 years of experience or Master’s degree with 2 years of experience or PhD in a relevant discipline.

Experience:

• Proven background in software systems engineering
  , requirements writing
  , and risk analysis
  .
• 2–4 years of experience in a regulated medical device or IVD environment required.
• Strong understanding of system lifecycle management
  , software verification/validation
  , and configuration management
  .

Technical

Skills:

• Experience with requirements management tools (e.g., DOORS, Jama, or similar).
• Familiarity with risk management frameworks (ISO 14971).
• Working knowledge of FDA 21 CFR Part 820
  , ISO 13485
  , and IEC 62304
  .
• Proficiency in software integration and testing
  .

Soft Skills:

• Excellent written and verbal communication skills.
• Strong organizational and time management abilities to manage multiple projects.
• Collaborative mindset and the ability to influence cross‑functional teams.

Preferred Qualifications:

• Advanced understanding of software reliability, manufacturability, and usability
  .
• Experience in software architecture and system modeling
  .
• Familiarity with emerging IVD and diagnostic technologies
  .
• Strong analytical skills and ability to drive root cause analysis and risk mitigation
  .

Not Applicable

Contract

Biotechnology Research and Pharmaceutical Manufacturing

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