BEPC Inc. - Business Excellence Professional Consulting
System Engineer
BEPC Inc. - Business Excellence Professional Consulting, Oro Valley, Arizona, United States
Systems Engineer – Assay Development (BEPC Inc., Tucson, AZ)
Be among the first 25 applicants. This is a hybrid W2 contract 12 months with the possibility of extensions. This is a
no C2C
position. A healthier future drives us to innovate, continuously advance science, and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Overview
As a member of our 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. Responsibilities
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 associated risks, and define appropriate 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 the company‑specific tool. Qualifications
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). Experience in assay development at a medical device company. Demonstrated knowledge of systems engineering principles, specifically in requirements engineering, trade‑off analysis, risk management, configuration management, and verification and validation. 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. 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. Preferred
Knowledge of Cytology assay development in a clinical workflow setting. Deep knowledge in requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development. Proven ability to build authority and accountability within a team, with strong collaboration and communication 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. Familiarity with the assay development process and its associated requirements, risks, and validation needs. Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart. Advanced understanding of software engineering, electronics, electro‑mechanical systems, information technology, and basic chemistry. Seniority Level
Mid‑Senior level Employment Type
Contract Job Function
Engineering and Research Industries
Biotechnology Research and Pharmaceutical Manufacturing Benefits
Medical insurance Vision insurance Location & Salary
Tucson, AZ – $95,000.00–$130,000.00 per year Referral Program
Referrals increase your chances of interviewing at BEPC Inc. - Business Excellence Professional Consulting by 2x.
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Be among the first 25 applicants. This is a hybrid W2 contract 12 months with the possibility of extensions. This is a
no C2C
position. A healthier future drives us to innovate, continuously advance science, and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Overview
As a member of our 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. Responsibilities
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 associated risks, and define appropriate 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 the company‑specific tool. Qualifications
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). Experience in assay development at a medical device company. Demonstrated knowledge of systems engineering principles, specifically in requirements engineering, trade‑off analysis, risk management, configuration management, and verification and validation. 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. 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. Preferred
Knowledge of Cytology assay development in a clinical workflow setting. Deep knowledge in requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development. Proven ability to build authority and accountability within a team, with strong collaboration and communication 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. Familiarity with the assay development process and its associated requirements, risks, and validation needs. Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart. Advanced understanding of software engineering, electronics, electro‑mechanical systems, information technology, and basic chemistry. Seniority Level
Mid‑Senior level Employment Type
Contract Job Function
Engineering and Research Industries
Biotechnology Research and Pharmaceutical Manufacturing Benefits
Medical insurance Vision insurance Location & Salary
Tucson, AZ – $95,000.00–$130,000.00 per year Referral Program
Referrals increase your chances of interviewing at BEPC Inc. - Business Excellence Professional Consulting by 2x.
#J-18808-Ljbffr