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 7000 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. Were passionate about providing healthcare professionals with the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
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.
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 companys contractors and internal personnel to ensure effective communication interpretation and implementation of Werfens 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
Minimum Knowledge & Experience required for the position:
Bachelors 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
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 individuals 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 contactfor 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 7000 employees around the world comprise our Werfen team.
Required Experience:
IC
Since 1959, we’ve harnessed our passion to create a history of innovative specialized diagnostics breakthroughs in vitro diagnostics, improve the quality of test results, and enhance patient care.