Systems Engineer - Integration
TalentBurst, Inc.
Tucson, AZ
Apply
JOB DETAILS
LOCATION
Tucson, AZ
POSTED
30+ days ago
Location: Tucson, AZ
Duration: 8 Months
Job Description:
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.
A healthier future. It's what drives us to innovate. To 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.
At Diagnostics, we have revolutionized cancer diagnostics worldwide through state-of-the-art testing automation. We provide more than 250 cancer tests and associated instruments, making us the leading global supplier of cancer diagnostic systems to the pathology market. Through excellence and innovation in science and engineering, our people are leading the discovery, development, and delivery of diagnostic systems and tissue-based cancer tests that are guiding the future of healthcare. This culture of constant innovation at Diagnostics fuels our vision: to empower our customers by providing the highest quality, most innovative cancer diagnostic solutions. We are passionate in our pursuit of diagnostic solutions that improve the practice of medicine because when we empower pathology professionals, we brighten the outlook for patients.
Responsibilities include:
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.
Who You Are
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.
Preferred
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 LucidSpark/LucidChart.
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.
#TB_EN
#ZR
About the Company
T
TalentBurst, Inc.
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!
COMPANY SIZE
5,000 to 9,999 employeesINDUSTRY
Staffing/Employment Agencies
FOUNDED
2002
WEBSITE
http://www.talentburst.com/