Systems Engineer - Assay Development jobs in United States
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TalentBurst, an Inc 5000 company ยท 16 hours ago

Systems Engineer - Assay Development

TalentBurst, an Inc 5000 company, is seeking a Systems Engineer for their R&D team. The role involves driving requirements definition, risk management, and verification & validation practices in projects related to IVD standards.

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H1B Sponsor Likelynote

Responsibilities

Drive requirements definition
Risk management
Verification & validation practices in projects
Defining requirements
Designing system architectures
Implementing solutions to meet IVD standards
Take ownership of project deliverables
Facilitate the decision-making process with well-considered tradeoffs

Qualification

Requirements writingRisk analysis (FMEA)Systems engineering principlesAssay developmentRETINA experienceLucidSpark/LucidChartOrganizational skillsCross-functional collaboration

Required

3-5 years of experience
Requirement writing experience in a regulated industry (medical device industry preferred)
Risk analysis (FMEA) work in an engineering discipline (regulated medical device company preferred)
Demonstrated knowledge of systems engineering principles, specifically in requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation
Ability to work cross-functionally with many stakeholders, weighing the needs of many stakeholders and coming to an alignment balancing all needs and tradeoffs
Bachelor's degree in Engineering is required

Preferred

Assay development experience - particularly with cytology specimens
Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart
Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities

Company

TalentBurst, an Inc 5000 company

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Founded in 2002, TalentBurst is an MBE and JCC certified firm that provides award winning solutions globally.

H1B Sponsorship

TalentBurst, an Inc 5000 company 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 (3)
2023 (7)
2021 (1)
2020 (4)

Funding

Current Stage
Late Stage

Leadership Team

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Jamie Jacobs (she/her)
Sr Vice President of Strategic Partnerships and DE&I/ESG Council
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