Systems Engineer - San Diego

About the company

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, with a workforce of over 7,000 employees.

About the role

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. This role involves documenting user requirements, developing system requirements, participating in product architecture and design, driving risk analysis, and supporting integration and testing activities for both on-market products and new product introduction. The System Engineer may interact with customers, clinicians, third-party vendors, manufacturers, and others. This role is fully onsite at our Scripps Ranch location.

Responsibilities

• Works with product management and marketing early in the development cycle to define and scope customer needs and required functionality.
• Responsible for the development of system requirements documentation.
• Applies architectural and design skills to work with senior development engineers to decompose system requirements into a structured hierarchy of progressively smaller, cohesive subsystems 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, and configuration management of the system and its subsystems and interfaces.
• Drives system integration, optimization, and root cause analysis with the development teams during system integration, alpha 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 breakdown schedule estimates as needed.
• Operates electrical, mechanical, digital equipment, and test fixtures as needed.
• Works well in a team and 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.
• Performs other duties as assigned with or without accommodation.

Qualifications

• BS/BA degree in CE, EE, ME, Biomedical, or related Engineering discipline required.
• 10+ years of 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 the application of Human Factors is desired.

Pay

The annual base salary range for this role is $150,000 to $180,000. Individual employee compensation will depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

Benefits

• Medical, dental, and vision insurance.
• 401k plan retirement benefits with an employer match.
• Paid vacation and sick leave.
• Sales roles are eligible for participation in a commission plan.
• Management and select professional roles are eligible for a performance-based bonus.