Senior Systems Engineer II

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. Overview Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Under the general direction of a functional manager, with moderate latitude for self‑direction, operates in one or more areas of responsibility within a specific function. Responsibilities Key Accountabilities Acts as an individual contributor, core team or technical lead for a specific project. Accountable for the completion of assigned deliverables in accordance with approved schedules. Authors documentation and participates in activities in support of design control. Independently plans, performs & prioritizes tasks that are complex in nature, in alignment with corporate goals. Analyzes and interprets data, identifying trends and formulating the next steps, while effectively performing trade off analysis, if required by the function. Leads, designs and/or develops one or more of the following: new test methods, specifications, technical apparatus, software and processes for complex components and functions. Identifies product defects and recognizes outliers in results. Able to explain and document product defects and their impact. Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries and promotes collaboration. Technical expertise in at least 1 area and emerging as a subject matter expert. Provides technical guidance to and/or supervision of other group members and cross‑functional technical teams. Able to mentor others. Provides technical support for or leads CAPA or complaint investigations. Independently generates predictable schedules for activities related to the function, understanding cross‑functional dependencies. Essential Functions May review and provide input to deliverables from other functions. Recommends and leads implementation of improvement initiatives to aid department practices. May be assigned CAPA ownership. Secondary Functions May review and provide input to deliverables from other functions. Recommends and leads implementation of improvement initiatives to aid department practices. May be assigned CAPA ownership. Budget Managed N/A Internal Networking / Key Relationships To be determined based on department needs, to include interactions such as: Will interface on a regular basis with groups across the organization as needed. Skills & Capabilities Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking Technically adept and confident Leadership: Accountability, Decision Making, Influence, Communication Mentoring Qualifications Education Bachelor's degree in Engineering, Science or a related field Experience Ten years of product development or relevant experience Six to eight years of product development or relevant experience for advanced degrees For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience In vitro medical device experience highly desired Additional Skills / Knowledge Language: Proficiency in English language required International Mobility Required: No Travel Requirements Some domestic and international travel may be required Compensation & Benefits The annual base salary range for this role is currently $130,000 to $160,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. Benefits include medical, dental, and vision insurance; 401k plan retirement benefits with an employer match; paid vacation and sick leave. Eligible for a performance‑based bonus. EEO Statement 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 View email address on click.appcast.io for assistance. #J-18808-Ljbffr Werfen North America