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Systems Engineer - Assay Development
Job in
Oro Valley, Pima County, Arizona, USA
Listed on 2026-02-19
Listing for:
Motion Recruitment Partners LLC
Full Time
position Listed on 2026-02-19
Job specializations:
-
Engineering
Systems Engineer, Biomedical Engineer
Job Description & How to Apply Below
Job Title:
Systems Engineer – Assay Development
Location: Oro Valley, AZ 85755
Duration: 11 Months Contract
Work Type: Onsite
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
- 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
- Assay development experience, especially with cytology specimens
- Prior experience with RETINA (Requirements & Test Integration Application)
- Familiarity with Lucid Spark and Lucid Chart
- Excellent organizational and prioritization skills with the ability to manage multiple projects
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