Systems Engineer - Assay Development

Engineer smart, safe, and scalable assay systems that set the standard in next‑generation IVD innovation.

R&D Partners is seeking a Systems Engineer - Assay Development to join our 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. You will define requirements, design system architectures, and implement solutions to meet IVD standards. This position requires ownership of project deliverables and facilitating decision-making processes with well-considered tradeoffs.

Applicants must have legal authorization to work in the United States.

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.

Key Skills and Requirements:

Must-Have:

• 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.

Ideal:

• 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.
• Bachelor's degree in Engineering is required.

Compensation: - only to be included for the above highlighted US locations!

For more information, please contact Toby Shelton.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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