Associate Systems Engineer - Assay Develompent

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

About the role

At Roche Tissue 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 fuels our vision: to empower our customers by providing the highest quality, most innovative cancer diagnostic solutions.

As a member of our R&D team, the Associate 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 Voice of Customer (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

Requirements

• Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 2 years of experience preferred
• Experience in assay development at a medical device company
• 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
• Experience working in the RETINA tool completing risk analysis and requirement work
• Demonstrated knowledge of systems engineering principles, specifically in requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation
• Deep knowledge in requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development
• 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

Pay

The expected salary range for this position based on the primary location of Arizona is $60,300 - $112,100 USD annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

This position qualifies for the benefits detailed at the provided link.