This position is with one of our direct clients. Please reach out to Aarti - asharma(at)divihn(dot)com or Anu - asiva(at)divihn(dot)com for more details about this position. You can also call Aarti - 630 847 1030 or Anu - 630 847 1017
Title: Validation Engineer
Validation Engineer will be working on a design history files (DHF) for the EU MDR project.
Will perform design verification/validation, process capability, and process control studies for product development organization. Will support RandD, Operations, and Quality Engineering function with the implementation and verification of process/technology. Will actively participate in and contribute to small to medium size projects, own assigned tasks, produce detailed requirements and analysis documents for assigned tasks. Partner with other support groups and remediation teams to complete work.
Must ensure deliverables are following regulatory quality standards through validations activities.
Responsible for creating the documents required for the development and validation of product designs.
Must be able to understand, design, and test products.
Responsible for ensuring the quality of work deliverables: writing, reviewing, and executing protocols and test cases for validations, coordinating testing and documentation of projects, and documenting/executing changes to deliverables. Will provide support to resolve technical issues with products under validation.
Must be able to function effectively as a member of a team including the ability to communicate effectively in written and verbal form.
Must perform all other duties and responsibilities as determined by supervision/management.
BS degree in Engineering Discipline (prefer Mechanical, Biomechanical, or Biomedical) with at least 3 years of experience in a regulated product development environment.
Ability to work with a diversified cross-functional team.
Self-motivated and work well without direct supervision.
Ability to quickly learn and understand applications.
Experienced with all typical software tools (MS Office Suite, Minitab, CAD SW prefer SolidWorks).
Occasionally may be required to lift up to 25 pounds, and must be able to walk, stand, reach and bend.
Interview Platform: Phone followed by onsite.
About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.