CountryUnited StatesShift1stAbout the Position Introduction WerfenWerfen 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 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.Responsibilities 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 documentationResponsible for conducting and documenting hazard and risk analysis for projectsDevelops system error budgets and conducts gage repeatability and reproducibility analysisSupports design activities as needed, and attends design reviewsManages continuous change, release & configuration management of the System, and it's sub systems and interfacesDrives system integration, optimization, and root cause analysis with the development teams during system integration, Alpa testing, and device pre-Beta testingWorks with the testing teams to develop strategies for system level product integration and testing; including software, electrical, analytic, and mechanical aspects of the systemSupports the clinical teams as needed to ensure a structured approach to product validationCreates work break down schedule estimates as neededOperates electrical mechanical, digital equipment and test fixtures as neededWorks well in a teamDevelops work products that reflect highly professional standardsDemonstrates excellent written and verbal communication skillsMay provide leadership to a small team of engineersMay participate in interviews for new department personnelMay work on process improvement activitiesOther duties as assigned with or without accommodationQualifications SKILLS/QUALIFICATIONS:BS/BA degree in CE, EE, ME, Biomedical or related Engineering discipline required10+ years industry experienceExperience in the full development lifecycle for product delivery to market of at least one product requiredExperience in Medical device development or other Regulated industry requiredExperience applying Six Sigma DMAIC as a means of improving, optimizing and stabilizing systems under development is desiredExperience applying DOE to systems under development is desiredExperience with UML is desiredExperience in application of Human Factors is desiredThe 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.#J-18808-Ljbffr