Integration Engineer at Werfen GmbH

Norcross, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Sep, 26

Salary

0.0

Posted On

11 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Verification, Design Validation, Protocol Development, Traceability Analysis, Risk Assessment, Assay Integration, Project Management, Technical Writing, Mathematical Analysis, Data Collection, Requirement Analysis, Experimental Design

Industry

Medical Equipment Manufacturing

Description

Introduction 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 with the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary 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. Responsibilities Key Accountabilities · 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 Networking/Key relationships Works in cross-functional relationships with quality and verification technologists Qualifications Minimum Knowledge & Experience required for the position: Bachelor’s degree (BS/BE) from four-year college or university; or equivalent combination of education and experience. • Biomedical Engineering Degree, preferred Skills & Capabilities: • 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 add apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks 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 Travel requirements: N/A Closing 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

Responsibilities

Develop and implement strategies for software, assay, reagent, and instrumentation verification and validation tests. Create study protocols, review results, and perform traceability analysis to ensure all requirements and specifications are fulfilled.