Systems Engineer - Software

BEPC Inc. - Business Excellence Professional Consulting; Tucson (AZ); On-site; USD 53,726 - 57,859; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Job summary

A business consulting firm in Tucson is seeking a Systems Engineer – Software to support cancer diagnostic solutions. The position involves software requirements development, risk analysis, and collaboration across various teams to optimize product design. Candidates should have a strong background in software systems engineering, with experience in regulated environments. This role offers a competitive hourly rate of $39-$42, paid weekly, with a comprehensive benefits package.

Qualifications

• 4+ years of experience for Bachelor's, 2+ years for Master's, or PhD in ED.
• Proven background in software systems engineering, requirements writing, and risk analysis.
• 2–4 years of experience in regulated medical device or IVD environment required.

Responsibilities

• Apply Systems Engineering principles to documentation and analysis.
• Author, review, and manage software requirements ensuring compliance.
• Conduct software risk analyses in alignment with medical standards.
• Work collaboratively across teams to translate needs into requirements.
• Support the design of compliant software architectures.
• Perform trade-offs to optimize software functionality.
• Participate in verification and validation activities.
• Identify and implement process improvements.
• Serve as a subject matter expert in systems and software integration.

Skills

Software systems engineering

Requirements writing

Risk analysis

Excellent written and verbal communication skills

Organizational skills

Time management abilities

Collaborative mindset

Education

Bachelor’s degree in Engineering or related field

Master’s degree in relevant discipline

PhD in a relevant discipline

Tools

DOORS

Jama

Job description

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.

BEPC Inc. - Business Excellence Professional Consulting provided pay range

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.

Base pay range

$39.00/hr - $42.00/hr

Role Overview

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.

Key Responsibilities

• 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.

Qualifications

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.

Seniority level

Not Applicable

Employment type

Contract

Job function

Biotechnology Research and Pharmaceutical Manufacturing

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