Tailored Management ยท 1 day ago
Systems Engineer - Software
Tailored Management is seeking a Systems Engineer to lead software product definition and development for Roche Tissue Diagnostics. The role involves applying Systems Engineering principles to define software requirements and manage projects that ensure compliance with IVD standards, while collaborating with various teams to innovate cancer diagnostic solutions.
ConsultingHuman ResourcesInformation Technology
Responsibilities
Apply Systems Engineering principles to define software requirements, perform risk assessments, and ensure compliance through verification and validation activities
Manage all aspects of software requirements, configuration, defect tracking, and testing deliverables in accordance with IVD standards
Partner closely with R&D, Quality, Regulatory, Marketing, and Operations teams to align product requirements and ensure design integrity
Evaluate emerging technologies, industry trends, and competitive offerings to support continuous product innovation and differentiation
Collaborate with business leaders and Voice of Customer (VoC) teams to translate user needs into robust technical solutions
Identify and resolve complex technical challenges through analytical approaches and structured decision-making
Qualification
Required
Bachelor's degree in Engineering, Biomedical Sciences, or a related technical discipline with 4+ years of experience, or a Master's degree with 2+ years, or a PhD in a relevant field
Proven expertise in software requirements engineering, risk management, configuration management, and system verification/validation
Ability to work independently and collaboratively across diverse functional teams
Strong analytical and problem-solving skills with attention to detail
Experience in a regulated medical device or IVD industry, familiar with FDA and ISO standards
Preferred
Proficiency in software reliability, usability, and manufacturability principles
Excellent communication, leadership, and organizational skills
Ability to prioritize and manage multiple projects in a fast-paced environment
Demonstrated interest in emerging technologies and innovation in diagnostics
Benefits
Weekly pay
Medical
Dental
Vision coverage
Company
Tailored Management
Tailored Management is a staffing and recruiting company that offers information technology staffing and recruitment services.
H1B Sponsorship
Tailored Management has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
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