Associate Systems Engineer

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

Country

United States

Shift

1st

About the Position

Introduction

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Job Summary

Werfen's Autoimmunity business line is looking for an Associate Systems Engineer. This role is an exciting opportunity for an early-career engineer 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, verification and validation activities, troubleshooting, and risk mitigation initiatives. This role is ideal for a motivated problem-solver who enjoys working in a fast-paced, regulated environment while leveraging analytical thinking, technical curiosity, and strong collaboration skills to help bring high-quality diagnostic products to life.

Responsibilities

Key Accountabilities

• Supports multiple medium- to large-sized projects associated with the development of new diagnostic instruments or improvements to existing in-vitro diagnostic instruments in accordance with established standards and procedures, including design control.
• Communicates project status, risks, and technical challenges to team leads and management.
• Participates in and/or performs system integration testing, verification, and validation activities across a project under minimal supervision.
• Executes, and analyzes verification and validation (V&V) activities, applying statistical tools, reliability analysis, and process optimization.
• Supports troubleshooting activities, failure investigations, and risk assessments, identifying root causes and implementing corrective and preventive actions.
• Utilizes data analytics and modeling techniques to optimize system performance.
• Ensures compliance and risk management standards.
• Responsible for contributing to the Design History File (DHF) for system, instrument, and software development projects and contributing to regulatory submissions.
• Participates in technical reviews and evaluations to ensure robust system design and risk mitigation.
• Works closely with Software, Hardware, Assay Development, Quality, and Manufacturing teams to support system integration and performance optimization.
• Provides input on and reviews user manuals, system specifications, and process improvements.

Networking/Key relationships

• R&D teams: Assay Development and Biomarker discovery
• Manufacturing and Operations Teams
• Quality & Regulatory Teams
• Global Systems Support
• Software and Hardware Teams (within Werfen or external)

Qualifications

Minimum Knowledge & Experience for the position:

Engineering or a related field with 0-3 years of relevant experience in systems engineering, biotech, or medical device development. Master’s degree preferred.

Skills & Capabilities:

• Ability to read and interpret the established Werfen procedures.
• Ability to lead, influence, and motivate people without direct authority. Ability to resolve conflict, manage expectations and negotiating skills.
• Excellent written and verbal communication skills for cross-functional collaboration
• Strong analytical and problem-solving skills, including root cause analysis.
• Statistical analysis skills prefered (DOE, regression analysis, capability studies)
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Experience in a regulated environment (FDA, ISO 13485, IEC 60601-1) a plus.

The annual base salary range for this role is currently $80k to $100k. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management,and select professional roles,are eligible for a performance-based bonus.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.