system engineer

The System Engineer works with the company’s development team by applying an interdisciplinary approach to the successful definition, development, integration, and testing of complex In Vitro Diagnostic systems., The system engineer documents user requirements, develops system requirements, participates in product architecture and design, drives risk analysis, and supports integration and testing activities for both on-market products as well as new product introduction. The system engineer may have interactions with customers, clinicians, third-party vendors, manufacturers, and others., * Works with product management and marketing early in the development cycle to define & scope customer needs and required functionality.

• Responsible for the development of the system requirements documentation.
• Applies architectural & design skills to work with senior development engineers to decompose the System Requirements Documentation into a structured hierarchy of progressively smaller, but cohesive sub-systems and well defined interfaces.
• Responsible for the creation of subsystem requirements documentation
• Responsible for conducting and documenting hazard and risk analysis for projects
• Develops system error budgets and conducts gage repeatability and reproducibility analysis
• Supports design activities as needed, and attends design reviews
• Manages continuous change, release & configuration management of the System, and it’s sub systems and interfaces
• Drives system integration, optimization, and root cause analysis with the development teams during system integration, Alpa testing, and device pre-Beta testing
• Works with the testing teams to develop strategies for system level product integration and testing; including software, electrical, analytic, and mechanical aspects of the system
• Supports the clinical teams as needed to ensure a structured approach to product validation
• Creates work break down schedule estimates as needed
• Operates electrical mechanical, digital equipment and test fixtures as needed
• Works well in a team
• Develops work products that reflect highly professional standards
• Demonstrates excellent written and verbal communication skills
• May provide leadership to a small team of engineers
• May participate in interviews for new department personnel
• May work on process improvement activities
• Other duties as assigned with or without accommodation

• BS/BA degree in CE, EE, ME, Biomedical or related Engineering discipline required
• 10+ years industry experience
• Experience in the full development lifecycle for product delivery to market of at least one product required
• Experience in Medical device development or other Regulated industry required
• Experience applying Six Sigma DMAIC as a means of improving, optimizing and stabilizing systems under development is desired
• Experience applying DOE to systems under development is desired
• Experience with UML is desired
• Experience in application of Human Factors is desired

The annual base salary range for this role is currently $150k to $180k. 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

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., 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.