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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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
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
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 StageCompany data provided by crunchbase