System Engineer

Overview

BEPC is seeking a highly motivated Systems Engineer I to join our client’s R&D team. The Systems Engineer will drive requirements definition, risk management, and verification & validation practices in projects, including defining requirements, designing system architectures, and implementing solutions to meet IVD standards. This individual will take ownership of project deliverables and facilitate the decision-making process with well-considered tradeoffs.

Base pay range
: $31.00/yr - $39.00/yr

Employment Type: 12-month contract with the possibility of extensions, Full Time

• System Lifecycle Management: Apply broad knowledge and skill sets from Systems Engineering, focusing on the requirements engineering, risk management, and verification & validation stages of the system lifecycle.
• Industry and Technology Analysis: Research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for robust requirements, proactive risk mitigation, and effective validation strategies.
• Cross-functional Collaboration: Work closely with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with organizational objectives and regulatory requirements, particularly regarding traceability, risk, and validation.
• Customer-Focused Innovation: Engage with business leaders and VoC representatives to ensure technical solutions align with customer needs and market demands, facilitating stakeholder discussions to prioritize requirements, assess risks, and define validation criteria.
• Technical Problem Solving: Analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address requirements definition, risk mitigation, and verification & validation challenges.
• Project Execution: Execute project deliverables specific to requirements engineering, risk analysis, configuration management, defect management, and verification & validation in company-specific tools.

• Educational Background: Bachelor’s degree in engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master’s degree with 2 years of experience, or a PhD).
• Systems Engineering Expertise: Demonstrated knowledge of systems engineering principles, specifically in requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.
• Regulatory Familiarity: Experience working in a regulated environment, with familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products, especially regarding requirements, risk, and validation.
• Strategic Mindset: Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD, with an eye for potential risks, critical requirements, and robust validation approaches.

• Specialized
  
  Skills:
  
  Deep knowledge in requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development.
• Leadership and Communication: Proven ability to build authority and accountability within a team, with strong collaboration and communication skills, particularly in facilitating discussions around complex requirements, risks, and validation plans.
• Organizational
  
  Skills:
  
  Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities; capability to formulate and solve problems, and complete work in a timely, accurate, and thorough manner, especially in managing extensive requirement sets, risk registers, and verification & validation matrices.
• Assay Development: Familiarity with the assay development process and its associated requirements, risks, and validation needs.
• Technical Tools: Prior experience in RETINA (Requirements & Test Integration Application) and with Lucid Spark/Lucid Chart.
• Advanced Knowledge: Advanced understanding of software engineering, electronics, electro-mechanical systems, information technology, and basic chemistry, to better define requirements, assess risks, and plan validation across system components.
• Pay Rate: $31.00 - $39.00 hr.
• Location: Tucson, AZ 85755
• Expected Duration: 12-month contract with the possibility of extensions
• Benefits: Health insurance, Life insurance, Vision insurance

• Bachelor’s (Required)

• Tucson, AZ 85755 (Required)

• Associate

• Systems Engineering

• Pharmaceutical Manufacturing and Biotechnology Research