R&D Partners · 14 hours ago
Systems Engineer (Medical Device)
R&D Partners is a global functional service provider specializing in scientific, clinical research, and engineering. They are seeking a Systems Engineer to drive requirements definition, risk management, and verification & validation practices in projects related to medical devices.
Staffing Agency
Responsibilities
Drive requirements definition
Risk management
Verification & validation practices in projects
Defining requirements
Designing system architectures
Implementing solutions to meet in vitro diagnostics standards
Take ownership of project deliverables
Facilitate the decision-making process with well-considered tradeoffs
Qualification
Required
Bachelor's degree in Engineering 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
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
Benefits
Medical insurance – PPO, HMO & HSA
Dental & Vision insurance
401k plan
Employee Assistance Program
Long-term disability
Weekly payroll
Expense reimbursement
Online timecard approval
Company
R&D Partners
R&D Partners is a national staffing agency that specializes in scientific, clinical, and engineering positions.