R&D Partners ยท 4 hours ago
Systems Engineer - Assay Development
R&D Partners is a leading life sciences recruiter, and they are seeking a Systems Engineer - Assay Development to join their client's RD team. In this role, you will drive requirements definition, risk management, and verification/validation practices for projects in the medical device industry.
Responsibilities
Define and document requirements in a regulated industry (medical device preferred)
Conduct risk analysis, including FMEA, within an engineering discipline
Apply systems engineering principles, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification/validation
Collaborate cross-functionally with stakeholders to align on project needs and tradeoffs
Qualification
Required
Applicants must have legal authorization to work in the United States
Define and document requirements in a regulated industry (medical device preferred)
Conduct risk analysis, including FMEA, within an engineering discipline
Apply systems engineering principles, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification/validation
Collaborate cross-functionally with stakeholders to align on project needs and tradeoffs
Requirement writing experience in a regulated industry (medical device industry preferred)
Experience with risk analysis and FMEA in an engineering discipline
Strong knowledge of systems engineering principles, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification/validation
Ability to work cross-functionally and balance stakeholder needs effectively
Bachelor's degree in Engineering is required
Preferred
Assay development experience, particularly with cytology specimens
Familiarity with RETINA (Requirements Test Integration Application) and LucidSpark/LucidChart
Excellent organizational skills with the ability to prioritize and manage multiple projects
Company
R&D Partners
R&D Partners is a national staffing agency that specializes in scientific, clinical, and engineering positions.