Systems Engineer - Assay Development jobs in United States
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Sharp Decisions · 6 hours ago

Systems Engineer - Assay Development

positionTucson, AZ
timeContract
remoteHybrid
seniorityMid Level

Sharp Decisions is seeking a Systems Engineer - Assay Development for a client in the biomedical/medical device sector. This role involves driving requirements definition and risk management while collaborating with cross-functional teams to ensure project success.

B2BHuman ResourcesInformation TechnologyStaffing Agency
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Senior Management
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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/LucidChartBachelor’s degree in EngineeringOrganizational skillsCross-functional collaboration

Required

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

Sharp Decisions

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Sharp Decisions is a staffing and recruiting company that offers technology and business staffing solutions.
dateFounded in 1990
location
New York, New York, USA
people-size201-500 employees
web-link
http://sharpdecisions.com

H1B Sponsorship

Sharp Decisions 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 (6)
2024 (13)
2023 (2)
2022 (10)
2021 (7)
2020 (10)

Funding

Current Stage
Growth Stage

Leadership Team

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Karen Ross
Founder, President and CEO
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Stuart Gottlieb
CFO/COO and Principal
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Company data provided by crunchbase