Staff Systems Engineer - Remote

Overview

The Staff Systems Engineer at DELFI Diagnostics will contribute to the design, development, validation, and launch of automated NGS-based diagnostics aimed at early cancer detection, working within a cross-functional team.

In Short

• Translate user needs into product requirements and specifications.
• Create and maintain design and development plans.
• Lead risk management activities and hazard analyses.
• Collaborate with cross-functional teams in assay development and laboratory operations.
• Troubleshoot and resolve engineering and laboratory issues.
• Support regulatory submission activities with technical documentation.
• Champion design control and systems engineering values.
• Become an expert on DELFI’s technology and processes.
• Establish verification and validation plans for new products.
• Develop and document work under design control systems.

Requirements

• BS or MS in relevant engineering fields.
• 12+ years of experience in systems or process engineering.
• Experience with 21 CFR 820 and ISO 13485.
• Knowledge of ISO 14971-compliant risk management.
• Experience with US-IVD regulatory submissions.
• Strong analytical and problem-solving skills.
• Excellent communication skills.
• Ability to master new concepts quickly.

Benefits

• 100% paid medical, dental, and vision premiums.
• 4 months paid parental leave.
• Flexible Time Off.
• 5 day winter break in December.
• A meaningful mission and strong company culture.