Systems Engineer (Medical Devices / IVD) jobs in United States
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Tranzeal Incorporated · 16 hours ago

Systems Engineer (Medical Devices / IVD)

Tranzeal Incorporated is seeking a Systems Engineer to support new product development for advanced cancer diagnostic instruments and assays. This role focuses on front-end systems engineering, including requirements definition, system architecture, risk analysis, and solution implementation in a regulated IVD environment.

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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Lead system-level requirements, architecture, risk analysis, and verification/validation activities
Apply Systems Engineering principles across the product lifecycle
Manage requirements, risk mitigation, and trade-off analyses
Collaborate cross-functionally with R&D, Marketing, Operations, Quality, and Regulatory teams
Analyze technical challenges, propose solutions, and support data-driven decisions
Research industry trends, emerging technologies, and competitive products
Engage with stakeholders and Voice of Customer teams to align solutions with customer needs

Qualification

Front-end Systems EngineeringRequirements DefinitionRisk ManagementTrade-off AnalysesHardware IntegrationRegulated Medical Device ExperienceFDA Standards KnowledgeISO Standards KnowledgeAnalytical SkillsCollaboration Skills

Required

Bachelor's degree in Engineering, Biomedical Sciences, or related field with 4+ years of experience (or Master's with 2+ years, or PhD)
Strong experience in front-end Systems Engineering (requirements, architecture, risk management)
Experience conducting trade-off analyses and working independently across teams
Familiarity with hardware and system integration, verification, and validation
Experience in a regulated medical device or IVD environment
Knowledge of FDA, ISO, and diagnostic product standards
Experience with requirements and risk tools

Company

Tranzeal Incorporated

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Tranzeal is an industry leading global Business Transformation Service Provider.

H1B Sponsorship

Tranzeal Incorporated 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
2025 (5)
2024 (6)
2023 (4)
2022 (6)
2021 (7)
2020 (15)

Funding

Current Stage
Growth Stage

Leadership Team

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Neha Varma
Associate Director- Client Partner
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Sheehan Khera
Client Partner
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Company data provided by crunchbase