System Engineer

Overview

Systems Engineer for software in regulated medical diagnostics, handling requirements, risk, and compliance.

Key Responsibilities

• requirement management
• process improvement
• systems engineering
• testing
• risk management
• architecture design

Tasks

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

Requirements

• doors
• iso 14971
• software integration
• fda 21 cfr
• bachelor's
• root cause

What You Bring

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. -Experience with requirements management tools (e.g., DOORS, Jama, or similar). -Familiarity with risk management frameworks (ISO 14971). -Advanced understanding of software reliability, manufacturability, and usability. -Strong analytical skills and ability to drive root cause analysis and risk mitigation -Proven background in software systems engineering, requirements writing, and risk analysis. -Familiarity with emerging IVD and diagnostic technologies. -Strong understanding of system lifecycle management, software verification/validation, and configuration management. -Excellent written and verbal communication skills. -Collaborative mindset and the ability to influence cross-functional teams. -Proficiency in software integration and testing. -Strong organizational and time management abilities to manage multiple projects. -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. -2–4 years of experience in a regulated medical device or IVD environment required. -Experience in software architecture and system modeling. -Working knowledge of FDA 21 CFR Part 820, ISO 13485, and IEC 62304.

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Benefits

Benefits: Medical, Dental, Vision, and Life Insurance Pay Rate: $39.00 – $42.00 per hour (Based on experience, paid weekly)

About Bepc Inc. - Business Excellence Professional Consulting

-Evolving from a technical consulting boutique, it expanded into IT project management and global talent services across borders. -Typical engagements include cleanroom commissioning, software and equipment validation, SAP deployment, and process automation. -Specializing in life sciences, high-tech manufacturing, automotive, IT systems, and construction sectors. -Operates a Mexico division catering to automotive and medical device clients, delivering engineering, validation, and automation services worldwide. -Known for seamless integration of Lean/Six Sigma methodologies with technical consulting to optimize client operations.

Sector Specialisms