Systems Engineer

Roche

4d

About The Position

This role is essential to support our current work and future expansion. As the Systems Engineer, you will be vital to ensuring our product development team can work efficiently with the latest technologies and systems. Your passion for integration and optimization will be crucial to the success of our cutting-edge laboratory. In this position, you are:
Integrating systems including automated staining systems, scanners, assays, and software updates.
Addressing issues promptly that may occur with the introduction of new instruments, assays or Software to ensure development efforts are not impacted.
Maintaining and troubleshooting systems to prevent and resolve any operational issues.
Analyzing complex technical challenges, present multiple solution paths, and help partners make informed decisions; provide innovative and clear options to address technical hurdles.
Working with multi-functional teams, including R&D, Marketing, Operations, Quality, and Regulatory to ensure alignment with organizational objectives and regulatory requirements. You will complete project deliverables specific to requirements, risk, configuration management, defect management, and verification and validation in the company specific tool.
Engaging with business leaders and Voice of Customer (VoC) representatives to ensure that technical solutions align with customer needs and market demands; facilitating team member discussions to prioritize features and enhancements.

Requirements

• You have a Bachelor’s in Engineering, Biomedical Sciences, or a related subject area field with 4 years of related experience, required.
• You have experience working in a regulated environment: demonstrating familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products.
• You have an strategic approach towards innovative technologies and understanding of the competitive landscape in IVD.
• Experience with authority and accountability within a team, with strong collaboration and communication skills.
• Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you have the ability to formulate and solve problems; you complete work in a timely, accurate and thorough manner.
• You have familiarity with the IVD product development process and system lifecycle process.

Nice To Haves

• A Master's degree with 2 years of related experience, or a PhD in a directly related field, is preferred.

Responsibilities

• Integrating systems including automated staining systems, scanners, assays, and software updates.
• Addressing issues promptly that may occur with the introduction of new instruments, assays or Software to ensure development efforts are not impacted.
• Maintaining and troubleshooting systems to prevent and resolve any operational issues.
• Analyzing complex technical challenges, present multiple solution paths, and help partners make informed decisions; provide innovative and clear options to address technical hurdles.
• Working with multi-functional teams, including R&D, Marketing, Operations, Quality, and Regulatory to ensure alignment with organizational objectives and regulatory requirements. You will complete project deliverables specific to requirements, risk, configuration management, defect management, and verification and validation in the company specific tool.
• Engaging with business leaders and Voice of Customer (VoC) representatives to ensure that technical solutions align with customer needs and market demands; facilitating team member discussions to prioritize features and enhancements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees