Indiana Stem Jobs

Mobile Indiana Career Connect Logo

Job Information

Cook Medical Design Assurance Engineer in Bloomington, Indiana

Overview

The Design Assurance Engineer at Cook Medical provides input, support and guidance to new product / process development (NPD) teams and ensures that documentation is compliant with established Cook Medical quality system requirements.

Responsibilities

• Coach and advise NPD teams on the application of Cook Medical global Design Controls, Process Development and Risk Management policies, procedures, and systems• Serve as a direct team member on assigned new product development projects, providing input into the project• Review project-related deliverables for compliance with Cook Medical policies and procedures• Contribute towards and participate in design reviews• Support development and deployment of Cook Medical global Design Controls, Process Development and Risk Management policies & procedures• Participate as global trainer/subject matter expert in specific procedures and systems, as requested

• Develop and maintain a broad understanding of Cook Medical Design Controls, Process Development and Risk Management policies, procedures, and systems• Maintain thorough knowledge of applicable regulations, standards, and guidance documents• Understand and be accountable for conducting Cook business with integrity and in compliance with applicable standards, including Cook policies• Within scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met

Qualifications

• Bachelor's degree in Engineering, preferably in Mechanical, Chemical, Manufacturing or Biomedical disciplines• Minimum 3 years experience in R&D and/or new product development, process development or quality assurance / quality engineering• Experience across broad range of Design Controls, Process Development and Risk Management procedures and systems

• Effective oral and written communication skills• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision

Physical Requirements:

• Approximately 95% of the time is spent in a normal office environment requiring sitting and moving around the building. Approximately 5% of time is spent in domestic/international travel to various locations to support project activities

• Collaborate with peers and Managers regularly through on-line communication methods at times during and outside of normal working hours being flexible in accommodating these demands• Must be able to perform the essential functions of the job, with or without reasonable accommodations

Posting Date2 weeks ago(4/7/2021 10:22 AM)

Requisition ID 2021-8340

Job Location(s) Bloomington IN United States

Travel Less than 10%

Position Type Full Time

Company Cook Medical Holdings

Category Engineering

DirectEmployers