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