Integration Engineer

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.

To develop and implement strategies for the creation of specific development and verification tests in the field of Software, Assay, Reagent, and Instrumentation. Implement aspects of the product development process related to design verification and validation.

• Assist with the creation and review of assay, software, and system requirements.
• Develop verification and study protocols to assure requirements and specifications are fulfilled.
• Review results of executed protocols and write summary reports and provide conclusions.
• Design and develop experiment studies for assay integration.
• Work with company’s contractors and internal personnel to ensure effective communication, interpretation, and implementation of Werfen’s procedures.
• Assist in project and product risk assessments.
• Perform traceability analysis of test protocol to requirement.
• Interact cooperatively with co‑workers, supervisors, and managers of other departments and receive direction well from superiors.
• Provide project management input regarding development and verification activities on projects.
• Adhere to domestic and international standards when developing study designs.

Works in cross‑functional relationships with quality and verification technologists.

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree (BS/BE) from a four‑year college or university; or equivalent combination of education and experience.
• Biomedical Engineering degree preferred.

• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

N/A

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 N for assistance.