Systems Engineer - Assay Development

Oro Valley, AZ, US • Posted 21 hours ago • Updated 9 hours ago

Contract W2

On-site

$45/hr

Motion Recruitment Partners, LLC

Fitment

Dice Job Match Score™

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Job Details

Skills

Regulatory Compliance
Systems Architecture
Collaboration
Research and Development
Manufacturing
Decision-making
Documentation
Test Management
Writing
Medical Devices
Risk Analysis
FMEA
Systems Engineering
Requirements Engineering
Risk Management
Configuration Management
Verification And Validation
Assays
Cell Biology
Management

Summary

Job Title: Systems Engineer - Assay Development
Location: Oro Valley, AZ 85755
Duration: 11 Months Contract
Work Type: Onsite
Job Summary
We are seeking an experienced Systems Engineer - Assay Development to join our R&D team. In this role, you will drive requirements definition, risk management, and verification and validation activities across regulated medical device development projects. The ideal candidate will have strong systems engineering expertise, experience working in regulated environments, and the ability to collaborate cross-functionally to deliver high-quality IVD solutions.
Key Responsibilities

Define, document, and manage system and subsystem requirements in compliance with medical device regulations
Lead systems engineering activities including requirements engineering, tradeoff analysis, risk management, and configuration management
Perform and maintain risk analyses (FMEA) throughout the product lifecycle
Support system architecture design and ensure alignment with project and regulatory requirements
Plan and support verification and validation (V&V) activities to ensure requirements are met
Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing
Take ownership of assigned deliverables and support informed decision-making through data-driven tradeoff analysis
Maintain clear documentation and traceability using requirements and test management tools

Required Qualifications (Must Have)

Bachelor's degree in Engineering or related field
Hands-on experience writing requirements in a regulated industry (medical device industry preferred)
Experience conducting risk analysis (FMEA) in an engineering discipline
Strong knowledge of systems engineering principles, including:
- Requirements engineering
- Risk management
- Tradeoff analysis
- Configuration management
- Verification and validation (V&V)
Proven ability to work cross-functionally with multiple stakeholders and balance competing priorities

Preferred Qualifications (Nice to Have)

Assay development experience, especially with cytology specimens
Prior experience with RETINA (Requirements & Test Integration Application)
Familiarity with LucidSpark and LucidChart
Excellent organizational and prioritization skills with the ability to manage multiple projects

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10105282
Position Id: 864131
Posted 21 hours ago

Company Info

About Motion Recruitment Partners, LLC

Motion Recruitment delivers IT Talent Solutions for Contract, Direct Hire, Managed Solutions and Statement of Work to all of North America from our 21 delivery centers. Our high-touch, specialized, team-based recruitment model’s success is proven through our exemplary track record in filling the most challenging IT positions for startup and enterprise clients alike. Our hyper-specialized tech focus results in a truly consultative approach for both our clients and candidates, within our recruiting areas of expertise: Software, Mobile, Data, Infrastructure, Cybersecurity, Product + UX and Functional.

Motion also delivers IT Consulting Solutions through the Motion Consulting Group (MCG) that create true digital transformation for IT projects in Agile Development & Coaching, DevOps & DevSecOps Solutions, and Managed Services for IT Operations.

We’re also the proud creators of Tech in Motion and the Timmy Awards, our North American community platform, events series and award program that connects over 250,000 tech enthusiasts to meet, learn, and innovate.

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