IVD Systems Engineer - Early-Career R&D & Integration

Werfenlife SA.; Northern, San Diego (KY, CA); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with employer match

Paid vacation

Job summary

Werfen's Autoimmunity business line is looking for an Associate Systems Engineer. This role offers an opportunity to contribute to the development and enhancement of innovative in-vitro diagnostic (IVD) systems that help improve patient outcomes worldwide.

As part of the R&D Systems Integration team, you will collaborate with cross-functional partners across software, hardware, assay development, quality, manufacturing, and regulatory functions to support system integration, design control,

Qualifications

• Engineering or related field with 0-3 years in systems engineering or medical devices.
• Master’s degree preferred.
• Experience in regulated environments (FDA, ISO 13485, IEC 60601-1) is a plus.
• Strong communication and collaboration skills.

Responsibilities

• Supports multiple medium- to large-sized projects for new or improved diagnostic instruments.
• Collaborates with Software, Hardware, Assay Development, Quality, and Manufacturing teams.
• Performs system integration testing, verification, and validation activities.
• Contributes to Design History File (DHF) and regulatory submissions.
• Communicates project status and risks to leads and management.

Skills

Systems engineering

Analytical thinking

Data analytics

Communication skills

Problem solving

Education

Engineering or related field (Bachelor's or Master’s preferred)

Tools

Microsoft Office (Excel, Word, PowerPoint)

Job description

Werfen's Autoimmunity business line is looking for an Associate Systems Engineer. This role offers an opportunity to contribute to the development and enhancement of innovative in-vitro diagnostic (IVD) systems that help improve patient outcomes worldwide.

As part of the R&D Systems Integration team, you will collaborate with cross-functional partners across software, hardware, assay development, quality, manufacturing, and regulatory functions to support system integration, design control,