BEPC Inc. - Business Excellence Professional Consulting · 1 day ago
System Engineer
BEPC Inc. is seeking an experienced Systems Engineer – Integration to support research and development initiatives for advanced diagnostic systems. This role focuses on requirements engineering, system integration, risk management, and verification & validation activities within a regulated IVD environment.
Responsibilities
Apply systems engineering principles across the system lifecycle with emphasis on:
Requirements engineering
Risk management
Verification and validation (V&V)
Define system architectures and integration strategies to meet regulatory and performance requirements
Execute configuration management, defect management, and V&V activities using company-standard tools
Develop, analyze, and manage complex system requirements with full traceability
Perform risk analysis and mitigation activities (e.g., FMEA)
Define and support robust verification and validation strategies aligned with regulatory standards
Identify tradeoffs and guide technical decision-making with data-driven recommendations
Partner closely with R&D, Quality, Regulatory, Operations, and Marketing teams
Facilitate stakeholder discussions to prioritize requirements, assess risks, and define validation criteria
Ensure alignment with organizational objectives and regulatory expectations
Investigate complex technical challenges and present multiple solution paths
Support system robustness through troubleshooting, analysis, and continuous improvement
Analyze industry trends, emerging technologies, and competitive products to inform system requirements and risk strategies
Qualification
Required
Bachelor's degree in Engineering, Biomedical Sciences, or a related technical field with 4+ years of experience
OR Master's degree with 2+ years of experience
OR PhD
Demonstrated experience in systems engineering, including: Requirements engineering
Tradeoff analysis
Risk management
Configuration management
Verification & validation
Experience working in regulated environments (FDA, ISO, or similar standards)
Strong analytical, problem-solving, and documentation skills
Excellent written and verbal communication skills
Ability to manage multiple priorities and complex projects
Preferred
Deep experience with: Requirements elicitation and management
Risk analysis methodologies (e.g., FMEA)
Usability engineering
V&V test strategy development
Familiarity with assay development processes
Experience with RETINA (Requirements & Test Integration Application)
Experience using LucidSpark or LucidChart
Advanced understanding of: Software engineering
Electronics and electromechanical systems
Information technology
Basic chemistry
Strong leadership presence and ability to facilitate complex technical discussions
Company
BEPC Inc. - Business Excellence Professional Consulting
BEPC Incorporated provides Technical Engineering and Information Technology Project Management services to Fortune 500 companies in the industries: Life Science, Engineering, Manufacturing, Information Technologies, Advanced Technologies, Automotive, and Construction.
H1B Sponsorship
BEPC Inc. - Business Excellence Professional Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (3)
2020 (3)
Funding
Current Stage
Growth StageCompany data provided by crunchbase