Early-Career Systems Engineer, IVD Diagnostics

Werfen; San Diego (CA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k plan with employer match

Paid vacation and sick leave

Performance-based bonus

Job summary

Werfen is hiring an Associate Systems Engineer in San Diego, CA to contribute to the development and integration of innovative in-vitro diagnostic systems. You will work with software, hardware, and assay development teams to support design control, verification, validation, and risk mitigation in a regulated environment.

The role emphasizes collaboration, data analytics, troubleshooting, and contributing to DHF and regulatory submissions, with exposure to ongoing system optimization and quality

Qualifications

• Bachelor’s degree in Systems Engineering, Bioengineering, Mechanical Engineering, or Electrical Engineering.
• 0-3 years of relevant experience in systems engineering, biotech, or medical device development; Master’s degree preferred.

Responsibilities

• Supports multiple medium- to large-sized projects for new or improved diagnostic instruments with design control.
• Documents project status, risks, and technical challenges for team leads and management.
• Performs system integration testing, verification, and validation across projects.
• Conducts V&V activities using statistical tools and risk-based approaches.
• Supports troubleshooting, root cause analysis, and corrective actions in a regulated environment.
• Collaborates with Software, Hardware, Quality, Manufacturing teams to optimize system performance.

Skills

Analytical thinking

Problem solving

Written and verbal communication

Leadership without authority

Cross-functional collaboration

Root cause analysis

Education

Bachelor’s degree in Systems Engineering

Bachelor’s degree in Bioengineering

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Electrical Engineering

Master’s degree preferred

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

Werfen is hiring an Associate Systems Engineer in San Diego, CA to contribute to the development and integration of innovative in-vitro diagnostic systems. You will work with software, hardware, and assay development teams to support design control, verification, validation, and risk mitigation in a regulated environment.

The role emphasizes collaboration, data analytics, troubleshooting, and contributing to DHF and regulatory submissions, with exposure to ongoing system optimization and quality