Job description

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. Position Summary: 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. This role is fully onsite at our Scripps Ranch location. DUTIES/RESPONSIBILITIES: • 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 SKILLS/QUALIFICATIONS: • 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. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 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 NAtalentacquisition@werfen.com 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. www.werfen.com #LI-GS1

Requirements

Must-haves

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 is fully onsite at our Scripps Ranch location.
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.
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

Nice-to-haves

None flagged.

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: icims
Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

401k